MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for VACCESS CT LOW-PROFILE POWER-INJECTABLE IMPLANTABLE PORT 7380000 manufactured by Bard Access Systems, Inc..
[126654100]
Pt had a port-a-cath placed. It was found to have become disconnected via imaging. Thirteen days later, the catheter portion of the pac was removed and one week after that, the port itself was removed and replaced with a new device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8054640 |
| MDR Report Key | 8054640 |
| Date Received | 2018-11-09 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-10-24 |
| Report Date | 2018-11-02 |
| Date Reported to FDA | 2018-11-02 |
| Date Reported to Mfgr | 2018-11-09 |
| Date Added to Maude | 2018-11-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VACCESS CT LOW-PROFILE POWER-INJECTABLE IMPLANTABLE PORT |
| Generic Name | PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
| Product Code | LFJ |
| Date Received | 2018-11-09 |
| Model Number | 7380000 |
| Catalog Number | 7380000 |
| Lot Number | RECV0264 |
| Device Availability | Y |
| Device Age | 21 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS, INC. |
| Manufacturer Address | 605 NORTH 5600 WEST SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-09 |