BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD

    MDR report key: 3151783 · Received June 4, 2013

    Report

    Report Number
    MW5030444
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DOZENS OF CLOTTED SPECIMENS FROM NEONATES IN OUR NICU. SPECIMENS DRAWN BY NURSES WITH WELL OVER 30 YRS EXPERIENCE WHO NEVER HAD CLOTTED SPECIMENS TO THIS EXTENT AND NOW HAVING FREQUENT CLOTTED SPECIMENS. THE BABIES HAVE TO BE RE-STUCK TWICE AND EVEN 3 TIMES TO GET A SATISFACTORY SPECIMEN. RETRAINING HAS BEEN DONE ON CORRECT HEEL STICK TECHNIQUES AND BLOOD COLLECTION ON CORRECT HEEL STICK TECHNIQUES AND BLOOD COLLECTION BUT ONLY A SMALL IMPROVEMENT IN THE NUMBER OF SPECIMENS NEEDING RECOLLECTED IS NOTED. CONSULTATION WITH (B)(6) REVEALED SIMILAR ISSUES FROM NURSES WHO, LIKE OURS HAVE 30+ YRS OF EXPERIENCE. FRUSTRATION IS HIGH DUE TO HAVING TO HAVE BABIES ENDURE SO MANY RE-DRAWS. SUSPECT ANTICOAGULANT IN TUBES LESS OR CHANGED IN LAST SEVERAL MONTHS THAT HAS CAUSED THIS DRASTIC INCREASE IN THE AMOUNT OF CLOTTED SPECIMENS - ESPECIALLY WHEN THE PRACTICE OF THE CAREGIVERS HAS NOT CHANGED IN THAT TIME - YET THE NUMBER OF CLOTTED SPECIMENS HAS SKYROCKETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246414 BD MICROTAINER TUBES JKA BECTON, DICKINSON AND CO. 3008138
    246415 BD MICROTAINER TUBES JKA BECTON, DICKINSON AND CO 2342106
    246551 BD MICROTAINER TUBES JKA BECTON, DICKINSON AND CO 3008139

    Patients

    Seq Age Sex Outcome Treatment
    1