MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for PU DP-44K DISP PUNCH 4.4MM manufactured by Teleflex Medical.
[144121989]
(b)(4). A visual inspection of the product involved in the complaint could not be conducted since the sample was not provided. An attempt to inspect current stock of material was made but at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time. The device history record of the product dp-44k batch number 74h1701864 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. Dhr shows that the product was assembled and inspected according to our specifications. No conclusion can be established at this time based on the lack of defective of sample. It is necessary the physical sample to perform a properly investigation. The customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause. If the sample becomes available this investigation will be updated with the evaluation results. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[144121990]
It was reported that while the doctor tried to use the aortic punch, the device did not work properly. The cut was not clean, and it did not finish the cut, so they had to use scissors to clean and finish the hole.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2019-00117 |
| MDR Report Key | 8574167 |
| Date Received | 2019-05-02 |
| Date of Report | 2019-04-19 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-04-19 |
| Device Manufacturer Date | 2017-08-15 |
| Date Added to Maude | 2019-05-02 |
| 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 | 0 |
| Brand Name | PU DP-44K DISP PUNCH 4.4MM |
| Product Code | DWS |
| Date Received | 2019-05-02 |
| Catalog Number | DP-44K |
| Lot Number | 74H1701864 |
| 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 | 2019-05-02 |