BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BLUE 3.5M 1M W/NDL

    MDR report key: 10016920 · Received May 1, 2020

    Report

    Report Number
    2210968-2020-03658
    Event Type
    Malfunction
    Date Received
    May 1, 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). 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 · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/10/2020. ADDITIONAL INFORMATION: D4, D10, H4. H3 EVALUATION: ONE EMPTY LABELED WINDING FORMER, ONE DETACHED NEEDLE AND ONE SUTURE OF PRODUCT CODE W8430, LOT MLQ834 WERE RECEIVED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE AS EXPECTED. THE BARREL HOLE WAS EXAMINED UNDER MAGNIFICATION FOR SUTURE REMNANT AND NONE WAS NOTED. ADDITIONALLY, THE SUTURE END WAS EXAMINED AND THERE ISN¿T SUFFICIENT IMPRESSION AT THE SWAGE END, RESULTING IN THE NEEDLE PULL OFF. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. PER THE CONDITION OF THE SAMPLE RECEIVED, THE ASSIGNABLE CAUSE OF THE PERFORMANCE DAMAGED PRODUCT IS A LIGHT SWAGE DEFECT, THIS DEFECT IS CAUSED WHEN DOES NOT TIGHTENS THE PRESS CORRECTLY AND THE SWAGE AREA BE WEAK ON THE NEEDLE/SUTURE. THE REPORTED COMPLAINT WAS VERIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO FDA: 04/30/2020 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, THE NEEDLE SEPARATED FROM THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482697 PROLENE BLUE 3.5M 1M W/NDL SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. MLQ834

    Patients

    Seq Age Sex Outcome Treatment
    1