BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA MULTI-PATIENT DISPOSABLE SET

    MDR report key: 1593498 · Received January 28, 2010

    Report

    Report Number
    2520313-2010-00005
    Event Type
    Malfunction
    Date Received
    January 28, 2010
    Date of Event
    December 28, 2009
    Report Date
    January 28, 2010
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Removal / Correction Number
    2520313-1/15/10-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE WAS NOT ABLE TO PROVIDE THE LOT NUMBER OF THE MPATS THAT WERE IN-USE DURING THE REPORTED ISSUES; HOWEVER, OUR RECORDS INDICATE THAT THE SITE RECEIVED LOT NUMBERS 820007 AND 820008, WHICH ARE CURRENTLY UNDER RECALL FOR FLASH IN ONE OF THE MOLDED PLASTIC COMPONENTS. ONE OF THE MPATS THAT WAS IN-USE IS BEING RETURNED FOR EVALUATION BUT HAS NOT BEEN RECEIVED AT THIS TIME. ALTHOUGH WE ARE UNABLE TO CONFIRM THE PRESENCE OF FLASH AT THIS TIME, IT IS POSSIBLE THAT THE DEVICE USED DURING THIS EVENT MAY HAVE CONTRIBUTED TO A MALFUNCTION, AS DEFINED IN 21 CFR 803. A FOLLOW-UP REPORT WILL BE SUBMITTED, ONCE OUR EVALUATION OF THE RETURNED PRODUCT IS COMPLETE.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THEY HAD TWO OCCURRENCES OF THE SALINE SIDE OF THE MULTI-PATIENT DISPOSABLE SET (MPAT) SPRAYING INSTEAD OF FLOWING IN A STEADY STREAM DURING PRIMING. THE SITE REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA MULTI-PATIENT DISPOSABLE SET ANGIOGRAPHIC TUBING SET DXT MEDRAD, INC. 3018231

    Patients

    Seq Age Sex Outcome Treatment
    1 AVANTA FLUID MANAGEMENT INJECTION SYSTEM