BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAMROCK

    MDR report key: 143691 · Received January 9, 1998

    Report

    Report Number
    1528105-1998-00001
    Event Type
    Malfunction
    Date Received
    January 9, 1998
    Date of Event
    December 19, 1997
    Report Date
    January 7, 1998
    Manufacturer
    WINFIELD MEDICAL INDUSTRIES
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER NOTIFIED THE DIST THAT THEY WERE HAVING PROBLEMS WITH A COMPONENT (THE 23G X 3/4" SHAMROCK BLOOD COLLECTION WINGED SET #10-1543 MFG BY WINFIELD MEDICAL INDUSTRIES) IN THEIR CLEAN BLOOD COLLECTION KIT THAT THE DIST MFRS. WAS USING A BLOOD DRAW KIT MADE FOR THE FACILITY BY JJ SKINNER INC. A SUBSIDIARY OF MCBAR MEDICAL INDUSTRIES INC. OF LOUISVILLE KY. THE 23G BUTTERFLY IN KIT HAD A LOOSE NEEDLE BECAUSE IT DISAPPEARED WHEN STICKING PT TO DRAW BLOOD. NEEDLE HAD BECOME RECESSED INSIDE TUBING OF BUTTERFLY AFTER STICKING PT. SMALL PORTION OF TIP PROTRUDED AND STUCK RIGHT THUMB ACCIDENTALLY. HAD PREVIOUS PROBLEM WITH BUTTERFLY WAS READY TO STICK PT, LOOKED AWAY AND LOOKED BACK AND NO NEEDLE ON BUTTERFLY, NEVER FOUND NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHAMROCK 23G X 3/4" WINGED SET JKA WINFIELD MEDICAL INDUSTRIES 10-1534 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *