MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2018-05-09 for UNKNOWN APHERISIS PORT UNK PORT manufactured by Bard Peripheral Vascular, Inc..
[107830082]
As the lot number for the device was not provided, a review of the device history records could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. 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.
Patient Sequence No: 1, Text Type: N, H10
[107830083]
It was reported the port was not able to be flushed successfully and there was no blood return either. The needle was replaced, pressure was applied to the port and the procedure was completed. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2020394-2018-00619 |
MDR Report Key | 7499903 |
Report Source | HEALTH PROFESSIONAL,OTHER,USE |
Date Received | 2018-05-09 |
Date of Report | 2018-05-09 |
Date of Event | 2018-04-16 |
Date Mfgr Received | 2018-04-16 |
Date Added to Maude | 2018-05-09 |
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 APHERISIS PORT |
Generic Name | SUBCUTANEOUS IMPLANTED APHERESIS PORT |
Product Code | PTD |
Date Received | 2018-05-09 |
Catalog Number | UNK PORT |
Lot Number | UNK |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2018-05-09 |