MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-16 for DEK BL MF 0 TC-43 2N 48" 833-123 manufactured by Teleflex Medical.
[31568967]
(b)(4). The device history review could not be conducted since the lot number was not provided. No device sample is expected. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[31568968]
Alleged event: the suture sheared at the junction of needle to suture. The needle remained in the carrier partially visible and angled upwards. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00347 |
| MDR Report Key | 5226104 |
| Date Received | 2015-11-16 |
| Date of Report | 2015-11-06 |
| Date of Event | 2015-10-30 |
| Date Mfgr Received | 2015-11-06 |
| Date Added to Maude | 2015-11-16 |
| 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 | 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 | 0 |
| Brand Name | DEK BL MF 0 TC-43 2N 48" |
| Product Code | MFJ |
| Date Received | 2015-11-16 |
| Catalog Number | 833-123 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-11-16 |