BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVACUATED COLLECTION NEEDLES

    MDR report key: 33106 · Received May 22, 1996

    Report

    Report Number
    MW1009142
    Event Type
    Malfunction
    Date Received
    May 22, 1996
    Date of Event
    May 10, 1996
    Report Date
    May 13, 1996
    Manufacturer
    SHERWOOD MEDICAL CO.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVACUATED COLLECTION NEEDLES WOULD LEAK DURING BLOOD DRAW FROM PT CREATING ADD'L BLOOD LOSS AND POSSIBLE EMPLOYEE EXPOSURE TO BLOODBORNE PATHOGENS. APPROX BLOOD LOSS 1CC TO 5CC OF BLOOD FLOWING FROM PT'S ARM TO CHAIR/BED OR FLOOR DURING PROCEDURE. DEFECTIVE MEDICAL DEVICE NOT USED. ITEM REMOVED FROM USE TO PREVENT POSSIBLE EXPOSURE TO EMPLOYEES IN DEPT. PURCHASING DEPT WILL NOT REORDER ITEMS AND DIFFERENT ITEM WILL BE PROVIDED TO LAB DEPT TECHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVACUATED COLLECTION NEEDLES EVACUATED COOLECTION NEEDLES JKA SHERWOOD MEDICAL CO. 515-13-36 238807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other