MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-19 for PU DP-48K DISP PUNCH 4.8MM manufactured by Teleflex Medical.
[127594788]
(b)(4). The device history review of the product dp-48k batch number 74g1701320 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. No nonconformance reports were originated for the lot in question that can be associated to the complaint reported. All materials used during the assembly met current specifications. The device history review shows that the product was assembled and inspected according to our specifications. The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[127594789]
It was reported that the device remained blocked during use on the iliac artery. The iliac artery was torn with ischemia of the leg. Surgical intervention was performed. The patient's current condition is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00340 |
| MDR Report Key | 8084710 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-10-26 |
| Date Mfgr Received | 2019-01-15 |
| Device Manufacturer Date | 2017-07-11 |
| Date Added to Maude | 2018-11-19 |
| 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 | PU DP-48K DISP PUNCH 4.8MM |
| Generic Name | INSTRUMENTS, SURGICAL, CARDIOV |
| Product Code | DWS |
| Date Received | 2018-11-19 |
| Returned To Mfg | 2018-12-17 |
| Catalog Number | DP-48K |
| Lot Number | 74G1701320 |
| 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 | 1. Required No Informationntervention | 2018-11-19 |