MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2014-09-29 for DEKNATEL BL MF 0 TC-43 2N 48 833-123 manufactured by Teleflex Medical.
[4913759]
It was reported that the physician was performing a sacrospinous fixation procedure using the capio slim device. After loading the suture and inserting it into the pt, the handle was depressed to deliver the needle and suture through the ligament. It felt a bit clunky on removal and the physician noticed that the suture had not been captured in the capio and the taper-cut needle was missing. It was confirmed that the needle detached (broke off) and was left inside the pt. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[12425236]
A sample is available for the mfr to evaluate. A device history record (dhr) review could not be conducted since the lot number was not provided. No corrective actions can be implemented due to the lack of product sample and batch number to perform a proper investigation and determine the root cause. Therefore, at this time the customer complaint cannot be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2014-00354 |
| MDR Report Key | 4138262 |
| Report Source | 01,05,06,08 |
| Date Received | 2014-09-29 |
| Date of Report | 2014-09-11 |
| Date of Event | 2014-08-21 |
| Date Mfgr Received | 2014-09-11 |
| Date Added to Maude | 2014-10-08 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JASMINE BROWN - REG AFFAIRS |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEKNATEL BL MF 0 TC-43 2N 48 |
| Generic Name | SUTURE NEEDLE |
| Product Code | MFJ |
| Date Received | 2014-09-29 |
| Catalog Number | 833-123 |
| 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 | RTP NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-29 |