MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-10 for BARD PORT AND CATHETER IMPLANTED SUBCUTANEOUS 2864 manufactured by Bard / C. R. Bard, Inc..
[123816532]
A (b)(6) y/o female pt with history of left breast cancer, who is s/p mediport insertion earlier this year in (b)(6). She has been undergoing neoadjuvant chemotherapy. Today, it was noted by her medical oncologist that the catheter did not have a good backflow. According to dr (b)(6) (oncologist), the catheter was flushed with saline, and he immediately noticed slight swelling in the subcutaneous pocket area. The pt was thus brought in for wound exploration, fluoroscopy, evaluation/revision of the mediport, possible removal. During the surgery, it was found that the catheter was disrupted between 5 and 6 cm from the tip, and on fluoroscopic view, the catheter tip was found to be retained in the right atrium. The remaining catheter and port were removed and transferred to higher level of care for foreign body removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080479 |
| MDR Report Key | 7957028 |
| Date Received | 2018-10-10 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-09-25 |
| Date Added to Maude | 2018-10-11 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | BARD PORT AND CATHETER IMPLANTED SUBCUTANEOUS |
| Generic Name | MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT |
| Product Code | PXK |
| Date Received | 2018-10-10 |
| Model Number | 2864 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD / C. R. BARD, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-10 |