MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-07-05 for HUDSON CONCHA RESERVOIR 1500, 1650ML 381-50 manufactured by Telefelx Medical.
[3653047]
The event is reported as: the customer reports an incomplete puncture of the concha reservoir bottle. No report of a patient injury.
Patient Sequence No: 1, Text Type: D, B5
[11079696]
A visual, dimensional and functional inspection could not be conducted since the product was not returned for evaluation. A device history record (dhr) review was conducted. The review showed no issues that may have contributed to any quality issues reported. All process parameters were within specification. All in-process qa inspections were acceptable. No sample returned from the customer to investigate. Complaint not confirmed. Root cause - unknown. Teleflex will continue to monitor feedback from customers on issues related to puncture port issues found during setup related to puncture port issues found during setup or administering respiratory therapy while utilizing water bottle products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417411-2013-00020 |
| MDR Report Key | 3217186 |
| Report Source | 06,07 |
| Date Received | 2013-07-05 |
| Date of Report | 2013-06-21 |
| Date of Event | 2013-06-17 |
| Date Mfgr Received | 2013-06-21 |
| Date Added to Maude | 2013-09-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN, SPECIALIST |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 900 WEST UNIVERSITY DR. |
| Manufacturer City | ARLINGTON HEIGHTS IL 60004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON CONCHA RESERVOIR 1500, 1650ML |
| Generic Name | CONCHA RESERVOIR BOTTLE, STERILE WATER |
| Product Code | BTC |
| Date Received | 2013-07-05 |
| Catalog Number | 381-50 |
| Lot Number | 01813A |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFELX MEDICAL |
| Manufacturer Address | ARLINGTON HEIGHTS IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-05 |