MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-03-21 for HUDSON TUBING, OXYGEN SUPPLY 7' 1115 manufactured by Teleflex Medical.
[70522048]
(b)(4). A visual inspection of the product involved in the complaint was performed on a picture provided by the customer of connector tfx-000195 (reduced hose end). No issues can be observed that can lead this customer complaint. A dimensional and functional inspection of the device involved in the complaint could not be conducted since the device was not returned. A device history record review could not be conducted since the lot number was not provided. Customer complaint cannot be confirmed based only on the information provided. In order to perform a proper investigation and determine the source of the alleged defect, it is necessary to evaluate the device involved on this complaint. However , material from the production line was functionally inspected according to tp-0152 and no issues were detected that can lead this customer complaint. If the device sample becomes available at a later date this complaint will be updated.
Patient Sequence No: 1, Text Type: N, H10
[70522049]
Customer complaint alleges that the device leaks from the joint between the oxygen tubing and the connector end. Alleged defect detected during use. No harm or injury to patient reported.
Patient Sequence No: 1, Text Type: D, B5
[71872529]
(b)(4). The sample was returned for evaluation. A visual exam was performed and no defects were observed. Functional testing was also performed and no issues were found. The sample passed the leak test. A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint. No non-conformance reports were originated for the lot in question that can be associated to the complaint reported. The dhr shows that the product was assembled and inspected according to specifications. Based on the investigation performed, the reported complaint could not be confirmed. The sample was evaluated and it was not possible to confirm the defect reported by the customer. No leakage was detected. The product was assembled and inspected according to specifications.
Patient Sequence No: 1, Text Type: N, H10
[71872530]
Customer complaint alleges that the device leaks from the joint between the oxygen tubing and the connector end. Alleged defect detected during use. No harm or injury to patient reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2017-00108 |
| MDR Report Key | 6421239 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-21 |
| Date of Report | 2017-03-13 |
| Date of Event | 2017-03-06 |
| Date Mfgr Received | 2017-03-31 |
| Date Added to Maude | 2017-03-21 |
| 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 | HUDSON TUBING, OXYGEN SUPPLY 7' |
| Generic Name | PRESSURE TUBING AND ACCESSORIES |
| Product Code | BYX |
| Date Received | 2017-03-21 |
| Returned To Mfg | 2017-03-20 |
| Catalog Number | 1115 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-21 |