BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD UD 18IN 5-0 S/A P-2 PRM

    MDR report key: 9310952 · Received November 12, 2019

    Report

    Report Number
    2210968-2019-89856
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    January 1, 2019
    Report Date
    October 22, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031040717
    PMA / PMN Number
    K022269
    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: 01/06/2020. ADDITIONAL H3 INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED FOR EVALUATION TO DETERMINE THE ASSIGNABLE CAUSE OF THE IT WAS REPORTED PERFORMANCE NEEDLE BREAKAGE; THEREFORE, THE REPORTED FAILURE COULD NOT BE EVALUATED. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED INCIDENT OF NEEDLE BREAKAGE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: 1. WERE BOTH LOTS TOTAL QUANTITY 2 DEVICE INVOLVED IN SAME PROCEDURE? YES. NOTE: EVENTS REPORTED VIA MW # 2210968-2019-89855, 210968-2019-89856.

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE BOTH LOTS TOTAL QUANTITY 2 DEVICE INVOLVED IN SAME PROCEDURE? YES. WILL THE PRODUCT BE RETURNED FOR INVESTIGATION? YES. NOTE: EVENTS REPORTED VIA MW # 210968-2019-89856.

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PCM110 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE BOTH LOTS TOTAL QUANTITY 2 DEVICE INVOLVED IN SAME PROCEDURE? DEVICE RETURN STATUS/ FOLLOW UP NOTE: EVENTS REPORTED VIA MW # 2210968-2019-89855, 2210968-2019-89856.

    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 WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106470 VCL CT BRD UD 18IN 5-0 S/A P-2 PRM SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. PCM110 10705031040717

    Patients

    Seq Age Sex Outcome Treatment
    1