MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,08 report with the FDA on 2012-06-14 for BONDEK GN BR 0 TC-43 2N 48" 833-213LP manufactured by Teleflex Medical.
[2728271]
The event is reported as: complaint alleges: "during preparation they had two sutures whose bullet just fell off and were very weak, break with little force when pulled. " no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9927056]
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. 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
| Report Number | 3004365956-2012-00221 |
| MDR Report Key | 2623372 |
| Report Source | 05,06,07,08 |
| Date Received | 2012-06-14 |
| Date of Report | 2012-06-01 |
| Date of Event | 2012-05-29 |
| Date Mfgr Received | 2012-06-12 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2012-10-11 |
| 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 | BONDEK GN BR 0 TC-43 2N 48" |
| Generic Name | CAPIO SUTURE |
| Product Code | MFJ |
| Date Received | 2012-06-14 |
| Catalog Number | 833-213LP |
| Lot Number | 02A0800188 |
| Operator | OTHER |
| 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 | 2012-06-14 |