MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-20 for MRI L/P PORT W/BROV 6.6F 0603880C manufactured by Bard Access Systems.
[180416480]
Images and photos were provided for review. The device has not been returned to the manufacturer for evaluation. As the lot number for the device was provided, a review of the device history records is not required. The investigation of the reported event is currently underway. (expiration date: 02/2022).
Patient Sequence No: 1, Text Type: N, H10
[180416481]
It was reported that approximately one week post port device implant, the port was allegedly unable to be aspirated. It was further reported that imaging was performed which demonstrated the port device to be alleged rotated upside down. Reportedly, the port device was removed and upon removal, the catheter was allegedly found detached from the port body connection. Additionally, imaging was reviewed which identified the port catheter to be in the left pulmonary artery. The patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00591 |
| MDR Report Key | 9735132 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-20 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-11-20 |
| Date Mfgr Received | 2020-03-26 |
| Date Added to Maude | 2020-02-20 |
| 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 | IMPLANTABLE PORT |
| Product Code | LJT |
| Date Received | 2020-02-20 |
| Catalog Number | 0603880C |
| Lot Number | REDQ4207 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-20 |