MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,company representati report with the FDA on 2015-07-01 for DEK BL MF 0 TC-43 2N 48 833-123 manufactured by Teleflex Medical.
[6265599]
Alleged event: capio suture broke inside needle carrier after the suture was passed into the sacrospinus ligament on the first pass. Another capio and suture was used complete the case. The suture head was caught in the bottom of the capio device. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[13705835]
(b)(4). The device history review could not be conducted since the lot number was not provided. The device sample has not been returned to the manufacturer for investigation at the time of this report. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[23703908]
(b)(4). The device history review of batch number 02j1001151 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. No rejection reports were originated for the lot in question. The device history shows that the product was assembled and inspected according to the manufacturer's specifications. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00187 |
| MDR Report Key | 4883395 |
| Report Source | 01,05,07,COMPANY REPRESENTATI |
| Date Received | 2015-07-01 |
| Date of Report | 2015-06-22 |
| Date of Event | 2015-05-26 |
| Date Mfgr Received | 2015-06-29 |
| Date Added to Maude | 2015-07-25 |
| 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 | 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 | 3 |
| Brand Name | DEK BL MF 0 TC-43 2N 48 |
| Generic Name | SUTURE |
| Product Code | MFJ |
| Date Received | 2015-07-01 |
| Catalog Number | 833-123 |
| Lot Number | 02J1001151 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-07-01 |