MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-06 for DEK BL MF 0 FX45/HR26 2N 48" BARD DEK100 manufactured by Teleflex Medical.
[30879109]
(b)(4). The device history record review could not be conducted since the lot number was not provided. The device sample is reportedly unavailable for return. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[30879110]
Alleged event: it was reported that during a sacral spinal fixation, after the suturing device did not capture the bullet, the bullet remained inside the patient. The surgeon attempted to pull on the suture to remove it, but it broke leaving the bullet embedded inside the patient. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00322 |
| MDR Report Key | 5208086 |
| Date Received | 2015-11-06 |
| Date of Report | 2015-10-13 |
| Date of Event | 2015-10-12 |
| Date Mfgr Received | 2015-10-13 |
| Date Added to Maude | 2015-11-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 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 | 0 |
| Brand Name | DEK BL MF 0 FX45/HR26 2N 48" BARD |
| Product Code | MFJ |
| Date Received | 2015-11-06 |
| Catalog Number | DEK100 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-06 |