BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 24IN 5-0 D/A C-1

    MDR report key: 9511556 · Received December 23, 2019

    Report

    Report Number
    2210968-2019-91244
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 4, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031019799
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 1/28/2020. ADDITIONAL INFORMATION: THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT MW 5091768. ADDITIONAL B5 NARRATIVE: IT WAS REPORTED THAT THE SUTURE SEPARATED FROM THE NEEDLE WHILE HANDLING THE SUTURE TO THE SURGEON OR WHILE THE SURGEON WAS SUTURING. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER LJH199 AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: SIXTEEN UNOPENED SAMPLES OF PRODUCT CODE (B)(4), LOT LJH199 WERE RECEIVED FOR ANALYSIS. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. DURING THE VISUAL INSPECTION OF THIRTEEN SAMPLES, NO DEFECTS WERE FOUND ON THE PACKAGES. THE SAMPLES WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRANDS AND NO DEFECTS WERE OBSERVED. A FUNCTIONAL TEST WAS PERFORMED AND THE PULL FORCE WERE ABOVE THE MINIMUM REQUIREMENTS. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. PER THE CONDITION OF THE SAMPLES, NO PERFORMANCE PULL OFF SUTURE NEEDLE WAS FOUND, AND THE TESTED SAMPLES MET THE FINISHED GOODS REQUIREMENTS. IF THE FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NOTE: EVENTS REPORTED VIA 2210968-2019-91243, 2210968-2019-91244.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING USE, THE NEEDLE PULLED OFF THE SUTURE WHILE SUTURING. THE DOCTOR USED LIKE SUTURE FROM A DIFFERENT LOT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE ACTUAL SUTURE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305349 PRLNE BLU 24IN 5-0 D/A C-1 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 8725H LJH199 10705031019799

    Patients

    Seq Age Sex Outcome Treatment
    1