MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2012-07-10 for DEK BL MF 0 TC-43 2N 48" 833-123 manufactured by Teleflex Medical.
[19571352]
Sample not available for investigation. Per device history report (dhr) investigation has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. Dhr shows that the product was assembled and inspected according to our specifications. No ncrms were issued for the lot number in question. Complaint cannot be confirmed and no corrective action can be implemented due to the lack of defective sample.
Patient Sequence No: 1, Text Type: N, H10
[19725440]
The following was reported as a follows: a doctor was using the capio device along with capio suture to perform a pelvic floor repair of a prolapsed uterus. After dissection he inserted the capio with the suture attached (access was difficult). The doctor pushed the capio trigger button but suture did not capture in tissue on removal of capio and suture it was noted that the tapercut needle was missing from suture; presumed lost inside the pt. The procedure continued using another suture with no further incidents. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2012-00241 |
| MDR Report Key | 2660822 |
| Report Source | 01,06,07 |
| Date Received | 2012-07-10 |
| Date of Report | 2012-06-26 |
| Date of Event | 2012-06-14 |
| Date Mfgr Received | 2012-07-05 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2012-10-24 |
| 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 | ELAINE BURKLE, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334957 |
| 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 | DEK BL MF 0 TC-43 2N 48" |
| Generic Name | CAPIO SUTURE |
| Product Code | MFJ |
| Date Received | 2012-07-10 |
| Catalog Number | 833-123 |
| Lot Number | 02J1102299 |
| 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 | 2012-07-10 |