BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BLUE 3.5M 1M W/NDL

    MDR report key: 10016070 · Received April 30, 2020

    Report

    Report Number
    2210968-2020-03655
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    January 1, 2020
    Report Date
    April 27, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH MEQ852 AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL H3 INVESTIGATION SUMMARY: ONE EMPTY LABELED WINDING FORMER AND ONE NEEDLE-SUTURE OF PRODUCT CODE W8430, LOT MEQ852 WERE RECEIVED FOR ANALYSIS. DURING VISUAL INSPECTION OF THE SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURE WAS EXAMINED ALONG OF STRAND AND DAMAGE (SPLIT AND FRAYING DEFECT) COULD BE OBSERVED. FUNCTIONAL TEST WAS PERFORMED AND THE TENSILE  STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. THE WINDING FORMER WAS VISUALLY INSPECTED AND DAMAGED ON THE FLAPS WERE NOTED. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. ACCORDING TO THE SAMPLE CONDITION, THE ASSIGNABLE CAUSE OF PERFORMANCE BREAKAGE SUTURE IS DAMAGED SUTURE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 06/29/2020. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THERE ANY ADVERSE PATIENT CONSEQUENCES? NO PATIENT CONSEQUENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THERE WAS A BIFURCATION IN THE SECOND HALF OF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479357 PROLENE BLUE 3.5M 1M W/NDL SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. MEQ852

    Patients

    Seq Age Sex Outcome Treatment
    1