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 2020-03-23 for PPRT MRI ISP 8GR INT 9808560 manufactured by Bard Access Systems.
[184757373]
Medical images were provided for review. As the lot number for the device was not provided, a review of the device history records could not be performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184757414]
It was reported that approximately three years, eight months and twelve days post port implant via the right internal jugular vein, during anticancer agent infusion, the device was allegedly unable to aspirate. It was further reported that during saline infusion, swelling and subcutaneous leak were allegedly identified. Therefore, the x-ray examination was performed which demonstrated catheter break and migration of the distal catheter segment near the pulmonary artery. Reportedly, distal catheter segment was removed. The patient was reported as stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00970 |
| MDR Report Key | 9866792 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-23 |
| 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 | 2020-03-23 |
| Model Number | 9808560 |
| Catalog Number | 9808560 |
| Lot Number | UNKNOWN |
| 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 | 2020-03-23 |