MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-08 for DEK BL MF 0 FX45 2N 48" BARD DEK200 manufactured by Teleflex Medical.
[25792656]
Alleged event: during a sacrospinal fixation procedure, the first suture went fine, the second suture failed: the bullet broke off the suture and the plug of the suture was left behind in the patient. No patient injury was reported and a new device was used to complete the procedure successfully.
Patient Sequence No: 1, Text Type: D, B5
[27444595]
(b)(4). Product code dek200 was received in its original packaging. Qty received: (b)(4), qty produced: (b)(4) each. No corrective actions will be implemented since the sample received met the functional specifications established in the manufacturing plant. Customer complaint cannot be confirmed based on the functional results obtained on the sample returned for evaluation. Sample demonstrated to be within specification due tensile strength results.
Patient Sequence No: 1, Text Type: N, H10
[27444596]
Alleged event: during a sacrospinal fixation procedure, the first suture went fine, the second suture failed: the bullet broke off the suture and the plug of the suture was left behind in the patient. No patient injury was reported and a new device was used to complete the procedure successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00281 |
| MDR Report Key | 5061534 |
| Date Received | 2015-09-08 |
| Date of Report | 2015-08-31 |
| Date of Event | 2015-08-28 |
| Date Mfgr Received | 2015-09-24 |
| Device Manufacturer Date | 2014-06-11 |
| Date Added to Maude | 2015-09-08 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 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 FX45 2N 48" BARD |
| Product Code | GAO |
| Date Received | 2015-09-08 |
| Returned To Mfg | 2015-09-08 |
| Catalog Number | DEK200 |
| Lot Number | 74F1401435 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2015-09-08 |