MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-02 for HEMOLOK TAKEAPART ML 5MM ENDO APPLIER 544965T manufactured by Teleflex Medical.
[107317919]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[107317920]
It was reported that while applying the clip, the jaw of the applier broke at the level of the rivet, and it seemed only one part of the screw was retrieve. After research another part was finally retrieved. There were no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2018-00114 |
| MDR Report Key | 7479897 |
| Date Received | 2018-05-02 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-06-08 |
| Date Added to Maude | 2018-05-02 |
| 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 | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEMOLOK TAKEAPART ML 5MM ENDO APPLIER |
| Product Code | HBT |
| Date Received | 2018-05-02 |
| Returned To Mfg | 2018-05-07 |
| Catalog Number | 544965T |
| Lot Number | P1400205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-02 |