MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2011-09-21 for DEKNATEL DEK BL MF 0 TC-43 2N 48" 833-123 manufactured by Teleflex Medical.
[16100283]
The event is reported as: complaint alleges: "planning on firing capio twice and on the first attempt the surgeon pulled the capio handle out of the vagina and noticed the bullet needle had pulled off the capio suture and the needle was caught in the cage. There was no suture left on the bullet needle - pulled right off the suture. They opened another same and procedure was finished without further complications. Surgeon commented that he had not applied any extra force. " add'l info received: the suture with the detached needle was removed from the pt. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[16243532]
No sample is available for the mfr to evaluate. A f/u report will be sent when investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2011-00395 |
| MDR Report Key | 2266870 |
| Report Source | 01,05,06,07,08 |
| Date Received | 2011-09-21 |
| Date of Report | 2011-09-13 |
| Date of Event | 2011-08-19 |
| Date Mfgr Received | 2011-09-13 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2012-04-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | AVE. TRANSFORMACION 5954 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 | DEKNATEL DEK BL MF 0 TC-43 2N 48" |
| Generic Name | CAPIO SUTURE |
| Product Code | MFJ |
| Date Received | 2011-09-21 |
| Catalog Number | 833-123 |
| Lot Number | 02F1001626 |
| 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 | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-21 |