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 2020-03-02 for PPRT MRI ISP 8GR INT 9808560 manufactured by Bard Access Systems.
[181648103]
The lot number was not provided, a review of the device history records has not been performed. The device has been returned for evaluation. The investigation is currently underway.
Patient Sequence No: 1, Text Type: N, H10
[181648104]
It was reported that approximately two years post port implant and during chemotherapy, the catheter was allegedly occluded by a thrombus. The patient is reportedly stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00702 |
| MDR Report Key | 9776548 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-03-02 |
| 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 | PPRT MRI ISP 8GR INT |
| Generic Name | IMPLANTABLE PORT |
| Product Code | LJT |
| Date Received | 2020-03-02 |
| Returned To Mfg | 2020-02-21 |
| Model Number | 9808560 |
| Catalog Number | 9808560 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-02 |