BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF-150ML BX50

    MDR report key: 2872023 · Received December 11, 2012

    Report

    Report Number
    9610849-2012-00008
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 11, 2012
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: ROOT CAUSE CANNOT BE IDENTIFIED SINCE SAMPLE WAS NOT RECEIVED FOR EVAL. CONCLUSIONS: DHR COULD NOT BE REVIEWED SINCE LOT NUMBER WAS NOT PROVIDED. CONDITIONS REPORTED WERE NOT CONFIRMED, SAMPLES WERE NOT RECEIVED FOR EVAL. CORRECTIVE ACTIONS: NO CORRECTIVE ACTIONS WILL BE TAKEN SINCE CONDITION REPORTED WAS NOT CONFIRMED; NO SAMPLES WERE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6): COVIDIEN SALES REP REPORTS VIA PHONE THAT THE CUSTOMER CALLED TO REPORT THE TIP OF THE SYRINGE DETACHED DURING A PEDIATRIC CARDIAC CATHETERIZATION PROCEDURE. PRODUCT MONITORING HAS MADE MULTIPLE ATTEMPTS, INCLUDING A LETTER SENT VIA (B)(6) TO OBTAIN ADDITIONAL PT AND PROCEDURAL INFO WITH NO RESPONSE FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML BX50 EMPTY, DISPOSABLE 150ML SYRINGE DXT COVIDIEN 150ML EMPTY SYR NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK