MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-04-08 for DEKNATEL DEK BL MF 0 TC-43 2N 48 833-123 manufactured by Teleflex Medical.
[5619349]
Alleged issue: after the surgeon had thrown and caught the suture on each side of the sacrospinous ligament, as he was pulling the suture out of the body, the taper-cut needle tip came off on both sides. The surgeon decided to leave these needle tips in the patient. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[13185300]
(b)(4). A device history record (dhr) review could not be conducted since the lot number was not provided. No corrective actions can be established since it is necessary to retrieve the physical sample to perform a proper investigation and to confirm the defect. At this time, due to the lack of defective product, it is not possible to confirm the complaint and to determine the root cause. The manufacturer will continue to monitor and trend relating complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00123 |
| MDR Report Key | 4671628 |
| Report Source | 01,05,06 |
| Date Received | 2015-04-08 |
| Date of Report | 2015-03-24 |
| Date of Event | 2015-02-19 |
| Date Mfgr Received | 2015-03-24 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2015-05-18 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JASMINE BROWN, REG. AFFAIRS |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD., RA |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEKNATEL DEK BL MF 0 TC-43 2N 48 |
| Generic Name | SUTURE NEEDLE |
| Product Code | MFJ |
| Date Received | 2015-04-08 |
| Catalog Number | 833-123 |
| Lot Number | 74F1401388 |
| Device Expiration Date | 2019-06-30 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-08 |