MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-13 for OEM UNKNOWN DUMMY MATERIAL manufactured by Teleflex Medical.
[62609127]
(b)(4). The device has not been returned for investigation at this time. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[62609128]
The bullet broke during a procedure. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
[66230896]
(b)(4). A dhr review could not be conducted since the lot number was not provided. A failure mode duplication could not be conducted at this time, due to the complaint stating an interaction with capio device, which is a device from customer (boston scientific) and not from teleflex plant. No corrective actions can be implemented due the lack of product sample and batch number to perform a proper investigation and determine the root cause. Customer complaint cannot be confirmed due the lack of product sample and batch number to perform a proper investigation and determine the root cause.
Patient Sequence No: 1, Text Type: N, H10
[66230897]
The bullet broke during a procedure. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2016-00458 |
| MDR Report Key | 6169038 |
| Date Received | 2016-12-13 |
| Date of Report | 2016-12-05 |
| Date of Event | 2016-12-01 |
| Date Mfgr Received | 2016-12-15 |
| Date Added to Maude | 2016-12-13 |
| 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 | 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 | OEM UNKNOWN DUMMY MATERIAL |
| Product Code | BSJ |
| Date Received | 2016-12-13 |
| Catalog Number | OEM UNKNOWN |
| 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 | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-13 |