BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR SINGLEDAY 2ML/HR 12PK

    MDR report key: 1973240 · Received January 28, 2011

    Report

    Report Number
    6000001-2011-00489
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 4, 2011
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. UPON RECEIPT, FLUID WAS ALSO NOTED IN THE BAG THAT ENCLOSED THE SAMPLE WHICH SUGGESTED LEAK MUST HAVE OCCURRED. THE SOURCE OF THE LEAKY FLUID WAS VISUALLY OBSERVED AND CONFIRMED AT THE CONNECTION OF THE BLUE WINGED CAP AND THE LUER BODY. THE WINGED CAP WAS VISUALLY NOTED TO BE ADEQUATELY FASTENED TO THE LUER BODY (THE CAP WAS NOT OVER-TIGHTENED OR UNDER-TIGHTENED). THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE OF THE LEAK WAS DUE TO MATERIAL BUILD UP IN THE CORE PINS OF THE INTERNAL DIAMETER OF THE BLUE WINGED LUER CAP CAUSING A ROUGH SURFACE. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) INFUSOR SINGLEDAY DEVICE WAS OBSERVED LEAKING DURING SET-UP. THE DEVICE IS FILLED WITH DESFERRIOXAMINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR SINGLEDAY 2ML/HR 12PK PUMP, INFUSION, ELASTOMERIC MEB 10H019

    Patients

    Seq Age Sex Outcome Treatment
    1 DESFERRIOXAMINE