BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB EXC GRN 8X18IN 0 S/A CT-1 CR

    MDR report key: 9831657 · Received March 13, 2020

    Report

    Report Number
    2210968-2020-02037
    Event Type
    Malfunction
    Date Received
    March 13, 2020
    Date of Event
    January 1, 2020
    Report Date
    February 18, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    UDI-DI
    10705031024229
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 3/13/2020. A MANUFACTURING RECORDS EVALUATION WAS PERFORMED FOR BATCH MJP788, CX21D AND NO NON-CONFORMANCE'S WERE IDENTIFIED. INVESTIGATION SUMMARY: TWO OPENED BOXES WITH AS TOTAL OF TWENTY UNOPENED SAMPLES OF PRODUCT CODE CX21D, LOT MJP788 WERE RECEIVED FOR ANALYSIS. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR ANALYSIS. DURING VISUAL INSPECTION OF UNOPENED SAMPLES, NO DEFECTS WERE FOUND ON THE PACKAGES. SAMPLES WERE OPENED AND CONTAINS EIGHT STRANDS; THE SWAGE AND ATTACHMENT AREA OF NEEDLE-SUTURES WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO DEFECTS OR DAMAGED WERE FOUND. A FUNCTIONAL TEST WAS PERFORMED AND THE PULL FORCE RESULTS MEET THE CUSTOMER REQUIREMENTS. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. PER THE CONDITIONS OF THE SAMPLES RECEIVED, NO PERFORMANCE NEEDLE PULL OFF WAS FOUND, AND THE TESTED SAMPLES MET THE FINISHED GOODS REQUIREMENTS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: SPECIFIC NUMBER OF SUTURES FROM THE 2 BOXES WHICH HAD NEEDLE PULL OFF ISSUE IN THIS PROCEDURE. - 16 QTY, EVERY ONE THAT THEY TRIED PULLED OFF. FOR EACH INVOLVED DEVICE, PLEASE SPECIFY WHEN DID THE ISSUE OCCUR- UPON DISPENSING (BEFORE USE ON PATIENT) OR DURING SUTURING? - IN OR DURING SUTURING. DID ANY DEVICE HAD SUTURE THREAD BROKEN DURING USE? IF YES, PLEASE PROVIDE QUANTITY OF DEVICES WITH SUTURE THREAD BROKEN ISSUE. - UPON USE, THE SUTURE POPPED OFF OF THE NEEDLE IMMEDIATELY. HOW WAS CASE COMPLETED? - WE USED A DIFFERENT SUTURE WITH A SMALLER NEEDLE. ANY PATIENT CONSEQUENCES?WHAT MEDICAL/SURGICAL INTERVENTION WAS PERFORMED TO MANAGE THEM? - N/A. NOTE: EVENTS REPORTED VIA MW 2210968-2020-02034, 2210968-2020-02035, 2210968-2020-02036, 2210968-2020-02037, 2210968-2020-02038, 2210968-2020-02039, 2210968-2020-02040, 2210968-2020-02041, 2210968-2020-02042, 2210968-2020-02045, 2210968-2020-02046, 2210968-2020-02047, 2210968-2020-02048, 2210968-2020-02049, 2210968-2020-02050, 2210968-2020-02051.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293013 EB EXC GRN 8X18IN 0 S/A CT-1 CR SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC. CX21D MJP788 10705031024229

    Patients

    Seq Age Sex Outcome Treatment
    1