MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-19 for BARD PTFE FELT 007959 manufactured by Bard Access Systems.
[142630816]
As the lot number for the device was not provided, a review of the device history records could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. The device is labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[142630878]
This report summarizes one malfunction event. A review of the event indicated that model 7959 bard ptfe felt experienced a material split, cut or torn. Of this event, the device was used on the patient with no reported injury. The patient was a (b)(6) year-old male with weight not provided. The 7959 bard ptfe felt was not returned to the manufacturer limiting investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2019-00502 |
| MDR Report Key | 8533458 |
| Date Received | 2019-04-19 |
| Date of Report | 2019-04-19 |
| Date Mfgr Received | 2019-03-31 |
| Date Added to Maude | 2019-04-19 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD SHANNON LIMITED |
| Manufacturer Street | SAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7 |
| Manufacturer City | HUMACAO 00791 |
| Manufacturer Postal Code | 00791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD PTFE FELT |
| Generic Name | PTFE FELT |
| Product Code | DXZ |
| Date Received | 2019-04-19 |
| Model Number | 007959 |
| Catalog Number | 007959 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-19 |