BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEATMAN SAC INTRODUCER

    MDR report key: 11720 · Received February 24, 1994

    Report

    Report Number
    MW1000862
    Event Type
    Injury
    Date Received
    February 24, 1994
    Date of Event
    February 4, 1994
    Report Date
    February 7, 1994
    Manufacturer
    CABOT MEDICAL CORP.
    Product Code
    HET
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    POOR PACKAGING. WHILE PERFORMING A LAPAROSCOPIC OOPHORECTOMY, A NON-STERILE PRODUCT WAS OPENED ONTO THE STERILE FIELD AND USED. THE DEVICE IS PACKAGED STERILE. THE "INTRODUCER" THAT IS USED WITH IT IS NON-STERILE BUT IS PACKAGED THE SAME WAY. THEY BOTH COME IN A BOX CONTAINING 20 STERILE RETRIEVAL DEVICES AND ONE NON-STERILE INTRODUCER. THEY ARE ALL PACKAGED IN "PEEL PACKS" WHICH IS THE STANDARD PACKAGING FOR SOME STERILE SUPPLIES. ALTHOUGH THE INTRODUCER IS LABELED "NON-STERILE," IT WAS OPENED AND USED, CONTAMINATING THE SURGERY. RPTR FEELS THAT DIFFERENT PACKAGING WOULD HAVE PREVENTED THIS INCIDENT. RPTR RECOMMENDS PACKING THE NON-STERILE INTRODUCER IN A SMALL BOX SO THAT IT WILL OBVIOUSLY APPEAR TO BE NON-STERILE OR STERILIZE IT FOR FIRST TIME USE. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEATMAN SAC INTRODUCER HET CABOT MEDICAL CORP. 3G 1031

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention