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 2020-02-27 for PPRT MRI ISP 8GR INT 9808560 manufactured by Bard Access Systems.
[181831922]
As the lot number for the device was provided, a manufacturing review will be performed. The device has not been returned to the manufacturer for evaluation and photos were provided for review. The investigation of the reported event is currently underway. (expiration date: 10/2021).
Patient Sequence No: 1, Text Type: N, H10
[181831926]
It was reported that approximately four weeks post port device implant, the patient allegedly experienced pain during saline infusion. It was further reported that the port device was allegedly occluded. Reportedly, the port body was removed and upon removal, fluoroscopy demonstrated catheter break and migration of the distal catheter segment to the heart. Additionally, the distal catheter segment was removed. The patient was reported as stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00644 |
| MDR Report Key | 9764844 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-27 |
| 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 | 2020-02-27 |
| Model Number | 9808560 |
| Catalog Number | 9808560 |
| Lot Number | REDQ2863 |
| 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 | 2020-02-27 |