MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-04 for MRI L/P PORT W/BROV 6.6F 0603880C manufactured by Bard Access Systems.
[182154819]
Photos were provided for review. The device has not been returned to the manufacturer for evaluation. As the lot number for the device was provided, a review of the device history records is currently being performed. The investigation of the reported event is currently underway. (expiration date: 08/2021).
Patient Sequence No: 1, Text Type: N, H10
[182154820]
It was reported that approximately seven months post port device implant, the health care provider allegedly noticed subcutaneous swelling near the port site when injecting saline. It was further reported, that chest radiograph and angiogram demonstrated that the port catheter has allegedly fallen off the port body and migrated to the right atrium. Reportedly, the port body and detached catheter were both removed by interventional procedure. The patient is currently in good condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00726 |
| MDR Report Key | 9788567 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-02-09 |
| Date Added to Maude | 2020-03-04 |
| 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 | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Street | BLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MRI L/P PORT W/BROV 6.6F |
| Generic Name | IMPLANTABLE PORT |
| Product Code | LJT |
| Date Received | 2020-03-04 |
| Catalog Number | 0603880C |
| Lot Number | RECV2773 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other; 2. Required No Informationntervention | 2020-03-04 |