MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-24 for BARD A13402 manufactured by Bard.
[4127196]
Found fragment of portacath in pulmonary artery. Portacath was inserted at (b)(6) hosp 4 weeks ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033624 |
| MDR Report Key | 3542276 |
| Date Received | 2013-12-24 |
| Date of Report | 2013-12-03 |
| Date of Event | 2013-12-03 |
| Date Added to Maude | 2013-12-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD |
| Generic Name | PORTACATH |
| Product Code | LNY |
| Date Received | 2013-12-24 |
| Model Number | A13402 |
| Lot Number | UNK |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD |
| Manufacturer Address | COVINGTON GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-24 |