MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-05 for PPRT MRI ISP 8GR INT 9808560 manufactured by Bard Access Systems.
[182411412]
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
[182411413]
It was reported that approximately thirty days post port placement via right internal jugular vein, allegedly a catheter break was identified between the 13cm and 14cm marks. Reportedly, the distal catheter segment migrated to the inferior vena cava and remains in the patient. It was further reported that the port was removed. The current patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00780 |
| MDR Report Key | 9794777 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-02-09 |
| Date Added to Maude | 2020-03-05 |
| 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 | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
| Product Code | LJT |
| Date Received | 2020-03-05 |
| Returned To Mfg | 2020-02-07 |
| 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. Life Threatening; 2. Required No Informationntervention | 2020-03-05 |