MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-01-25 for RUSCH NEOPRENE PECAN BAG 2L X 2 22170AP manufactured by Teleflex Medical.
[65694579]
(b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report. No photo of the alleged defect was provided. A device history record review shows that the device was assembled and inspected according to our specifications. No conclusion can be established at this time based on the lack of device of sample. It is necessary to have the physical sample in order to perform a proper investigation. Customer complaint cannot be confirmed. If the device sample becomes available at a later date, this investigation will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[65694580]
Customer complaint alleges that the "neck pulls away from the bag". Alleged defect was reported as detected prior to use/ during pre-testing. No report of harm or injury. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
[68498014]
(b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that the black neoprene insert was detached from the bag. No other defects were detected. Samples of current stock of bag part number 212211202rm (neoprene pecan bag 2l 22mm) lot no. 11686743 which were available at the warehouse were inspected with no issues found. Based on the investigation performed, the reported complaint was confirmed. During the visual inspection of the sample it was observed that the insert detached from the bag. Corrective actions cannot be defined and established at present time as the affected bag is a purchased component. A notification will be sent to the supplier to define if further analysis and actions are required. In addition, personnel from the assembly line have been notified for awareness. A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.
Patient Sequence No: 1, Text Type: N, H10
[68498015]
Customer complaint alleges that the "neck pulls away from the bag". Alleged defect was reported as detected prior to use/ during pre-testing. No report of harm or injury. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
[69984393]
Qn#(b)(4). The sample was returned to the supplier for evaluation. The results are as follows: the sample was visually inspected and it was observed that the 22mm ferrule was not attached to the product. Only the neck band was remained attached to the product. No tears or cracks observed throughout the bag. The diameter of ferrule returned was measured at 2 points and found to be within specification. The ferrule was then fit to the returned breathing bag. Testing was conducted and there was no detachment of the ferrule from the assembled neck of the bag. The manufacturing process was also reviewed and no issues were identified. There has been no change in the dipping process, material, mold, and design for this product. Based on the investigation performed, the reported complaint could not be confirmed. There were no issues found with the returned device. The sample met the requirement of security of attachment of ferrule to the assembled neck with no signs of disconnection in any part of the breathing bag.
Patient Sequence No: 1, Text Type: N, H10
[69984394]
Customer complaint alleges that the "neck pulls away from the bag". Alleged defect was reported as detected prior to use/ during pre-testing. No report of harm or injury. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2017-00036 |
| MDR Report Key | 6275848 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-01-25 |
| Date of Report | 2017-01-03 |
| Date of Event | 2016-12-26 |
| Date Mfgr Received | 2017-03-10 |
| Device Manufacturer Date | 2016-03-02 |
| Date Added to Maude | 2017-01-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH NEOPRENE PECAN BAG 2L X 2 |
| Generic Name | BAG, RESERVIOR |
| Product Code | BTC |
| Date Received | 2017-01-25 |
| Returned To Mfg | 2017-01-19 |
| Catalog Number | 22170AP |
| Lot Number | 74C1600783 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-25 |