BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE TOOMEY PISTON SYRINGE

    MDR report key: 3973112 · Received July 21, 2014

    Report

    Report Number
    3973112
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    OZBURN-HESSEY LOGISTICS
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ATTEMPTING TO OPEN A TOOMEY/PISTON SYRINGE FOR SCRUB NURSE AND NOTICED A HOLE IN THE PACKAGING. WENT BACK TO SUPPLY TO GET ANOTHER STERILE SYRINGE AND FOUND FOUR MORE OF THE SAME SYRINGES WITH THE SAME HOLE OR DEFECT IN THE PACKAGE NEAR THE PLUNGER AREA. THERE WAS ALSO A DISTINCT DIFFERENCE IN THE TACTILE FEELING OF THE PLASTIC; IT WAS NOT UNIFORM AND WAS THINNER, CREATING BALLOON EFFECT WHERE THE DEFECTS WERE FOUND. DEVICE LOCATED THAT DID NOT HAVE DEFECTIVE PRODUCT FOR USE IN PATIENT'S SURGERY. DELAY WHILE OBTAINING EQUIPMENT WITHOUT HOLE IN PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425112 MEDICHOICE TOOMEY PISTON SYRINGE PISTON SYRINGE FMF OZBURN-HESSEY LOGISTICS * 1308AK09A
    425113 MEDICHOICE TOOMEY PISTON SYRINGE PISTON SYRINGE FMF OZBURN-HESSEY LOGISTICS * 1308AK09A
    425114 MEDICHOICE TOOMEY PISTON SYRINGE PISTON SYRINGE FMF OZBURN-HESSEY LOGISTICS * 1308AK09A
    425115 MEDICHOICE TOOMEY PISTON SYRINGE PISTON SYRINGE FMF OZBURN-HESSEY LOGISTICS * 1308AK09A
    425126 MEDICHOICE TOOMEY PISTON SYRINGE PISTON SYRINGE FMF OZBURN-HESSEY LOGISTICS * 1308AK09A

    Patients

    Seq Age Sex Outcome Treatment
    1 *