MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-07 for UNKNOWN APHERSIS PORT ACCESS SYSTEM UNK APHERESIS PORT ACCESS SYS manufactured by Bard Access Systems.
[119536763]
No medical records or medical images have been made available to the manufacturer. As the lot number for the device was not provided, a review of the device history records could not be performed. The device is pending return to the manufacturer for evaluation. The investigation of the reported event is currently underway. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. : device not returned yet.
Patient Sequence No: 1, Text Type: N, H10
[119536764]
It was reported that the port is difficult to access unless the patient is sitting straight up with their legs down. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2018-02384 |
| MDR Report Key | 7855615 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-07 |
| Date of Report | 2018-11-26 |
| Date Mfgr Received | 2018-11-15 |
| Date Added to Maude | 2018-09-07 |
| 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 | 1625 W 3RD ST. |
| 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 | UNKNOWN APHERSIS PORT ACCESS SYSTEM |
| Generic Name | SUBCUTANEOUS IMPLANTED APHERESIS PORT |
| Product Code | PTD |
| Date Received | 2018-09-07 |
| Catalog Number | UNK APHERESIS PORT ACCESS SYS |
| Lot Number | UNK |
| 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 | 2018-09-07 |