BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX1 TISSUE REMOVAL STSTEM - SUPPLY KIT

    MDR report key: 4203437 · Received October 23, 2014

    Report

    Report Number
    3009750704-2014-00573
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 23, 2014
    Manufacturer
    TENEX HEALTH
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DISCUSSION WITH THE DISTRIBUTOR FOUND THAT THERE WAS NO ALLEGATION OF THE STERILE BARRIER BEGIN BREACHED. THE CENTERS WERE CONCERNED THAT AN UNINTENTIONAL BREACH COULD OCCUR IF A SCRUB OR CIRCULATING NURSE OPENED THE POUCH AND DUMPED THE CONTENTS OUT. THE LABELING OF THE DEVICE WAS EVALUATED. THERE IS NO LABELING ON THE POUCH OR IN THE INSTRUCTIONS FOR USE STATING THAT THE PROCEDURE KIT IS STERILE. THE MEDICAL DEVICE, THAT SHIPS IN CONJUNCTION WITH THE PROCEDURE KIT, IS STERILE AND IS APPROPRIATELY LABELED AS SUCH. IN INSTANCES WHERE THE PROCEDURE KIT OPENED AND DUMPED ON THE STERILE BARRIER, THE ATTENDANT HAS NOT READ THE LABELING ON THE PACKAGE TO VERIFY STERILITY OR NON-STERILITY OF THE PRODUCT. TO MITIGATE THIS TYPE OF OCCURRENCE THE MANUFACTURER HAS DECIDED TO CHANGE THE PACKAGING TO A ZIPLOC STYLE BAG WHICH WOULD INDICATE NON-STERILITY BY THE BAG DESIGN.

    Description of Event or Problem · 1

    A DISTRIBUTOR OF THE PRODUCT REPORTED THAT ALTHOUGH THE MANUFACTURER SENT OUT A LETTER REGARDING THE NEW PACKAGING REITERATING THAT THE PACKAGE CONTAINING THE ANCILLARY ITEMS FOR THE PROCEDURE WAS NON-STERILE, MOST OF THE TIME INFORMATION REGARDING THE NON-STERILITY DID NOT GET CONVEYED TO THE SCRUB OR CIRCULATING NURSE. THE NURSE IS TYPICALLY THE ONE WHO OPENS THE ITEMS UP AND WITHOUT THIS INFORMATION COULD EMPTY EVERYTHING OUT ON THE STERILE FIELD. THREE MEDICAL CENTERS HAVE REQUESTED THAT A RED LABEL BE PLACED ON THE POUCH STATING NON-STERILE-OPEN ITEMS INDIVIDUALLY AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675761 TX1 TISSUE REMOVAL STSTEM - SUPPLY KIT TX SUPPLY KIT LFL TENEX HEALTH 554-1001-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other