BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ VIO 3X18IN 2 S/A CTXB CR

    MDR report key: 8805160 · Received July 18, 2019

    Report

    Report Number
    2210968-2019-84467
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Report Date
    June 24, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031134300
    PMA / PMN Number
    K810428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUMMARY: ONE EMPTY OPENED FOLDER, A DETACHED NEEDLE AND ONE DISPENSED SUTURE WERE RETURNED FOR ANALYSIS. THE PRODUCT CODE IS CONTROL RELEASE AND REQUIRED THREE STRANDS PER PACKET. DURING THE VISUAL INSPECTION OF THE NEEDLE THE SWAGE AND ATTACHMENT AREA WERE AS EXPECTED. THE BARREL HOLE OF THE NEEDLE WAS EXAMINED AND NO SUTURE REMNANT WAS NOTED. THE SUTURE WAS EXAMINED, AND THE INSERTION DID NOT MEET THE REQUIREMENT. THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE BATCH NUMBER IS UNKNOWN. PER THE SAMPLE CONDITION, THE ASSIGNABLE CAUSE OF THE PERFORMANCE - PULL OFF - SUTURE NEEDLE IS A SHORT INSERTION. THIS DEFECT IS CAUSED BECAUSE THE INSERTION OF THE SUTURE IN THE NEEDLE WAS INSUFFICIENT FROM KEEP THE NEEDLE/SUTURE UNION DURING TRANSPORTATION OR USE.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN 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 UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT AVAILABLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599056 VCL+ VIO 3X18IN 2 S/A CTXB CR SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. 10705031134300

    Patients

    Seq Age Sex Outcome Treatment
    1