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 2018-10-24 for PU DP-40K DISP PUNCH 4.0MM manufactured by Teleflex Medical.
[124833540]
(b)(4). The device has not been returned for investigation. A complaint history review was conducted on the catalog number in question. No complaints were received in this range with the same issue. Since the lot number provided (2400021) is not valid a dhr review could not be completed. The customer complaint cannot be confirmed since a product sample was not provided to perform a proper investigation and determine a root cause. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[124833541]
It was reported that during a cabg the physician had to push the aortic punch twice instead of once to punch through the aorta.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00315 |
| MDR Report Key | 7999568 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-09-25 |
| Date Mfgr Received | 2018-10-11 |
| Date Added to Maude | 2018-10-24 |
| 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 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 | 3 |
| Brand Name | PU DP-40K DISP PUNCH 4.0MM |
| Generic Name | INSTRUMENTS, SURGICAL, CARDIOV |
| Product Code | DWS |
| Date Received | 2018-10-24 |
| Catalog Number | DP-40K |
| Lot Number | 2400021 |
| 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 | 2018-10-24 |