MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-08 for DEKNATEL BON GN BR 0 TC-43 2N 48" 833-213LP manufactured by Teleflex Medical.
[5651993]
Complaint alleged per (b)(4) report: the bulleted needle popped off the suture and was lost in the pt. An x-ray was done to try to located the bullet. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[13157164]
Qn# (b)(4). Device history record (dhr) investigation did not show issues related to this complaint. Device sample received by mfr, but investigation is still underway at time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00120 |
| MDR Report Key | 4707412 |
| Report Source | 05,06 |
| Date Received | 2015-04-08 |
| Date of Report | 2015-03-12 |
| Date of Event | 2014-10-24 |
| Date Mfgr Received | 2015-03-12 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2015-06-02 |
| 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 |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD. |
| 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 BON GN BR 0 TC-43 2N 48" |
| Generic Name | NEEDLE |
| Product Code | GAO |
| Date Received | 2015-04-08 |
| Returned To Mfg | 2015-03-23 |
| Catalog Number | 833-213LP |
| Lot Number | 02A1401752 |
| Device Expiration Date | 2019-01-31 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 |