MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-26 for MRI L/P PORT W/BROV 6.6F 0603880C manufactured by Bard Access Systems.
[181179222]
Medical images and photos were provided to the manufacturer. As the lot number for the device was not provided, a review of the device history records has not been performed. The device is not available for return. The investigation is currently underway. The catalog number identified has not been cleared in the us, but is similar to the mri l/p port w/brov 6. 6f products that are cleared in the us. The 510 k number and pro code for the mri l/p port w/brov 6. 6f products are identified. (expiry date: 09/2021).
Patient Sequence No: 1, Text Type: N, H10
[181179223]
It was reported that eight months post port and catheter placement, the catheter allegedly had fallen into the heart. It was further reported that upon removal of the catheter, it was allegedly found to be detached from the port body. The port body and catheter were removed in two procedures. The patient was reportedly stable post removal procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00616 |
| MDR Report Key | 9753051 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-26 |
| 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 | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
| Product Code | LJT |
| Date Received | 2020-02-26 |
| Catalog Number | 0603880C |
| Lot Number | RECX2342 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-26 |