BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NW3328 ETHILON 3-0 26MM 70CM C

    MDR report key: 11505916 · Received March 17, 2021

    Report

    Report Number
    2210968-2021-02397
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    January 1, 2021
    Report Date
    February 17, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH MANUFACTURING RECORDS OF NW3328/ B8002 WAS REVIEWED FOR ANY PROCESS DEVIATION BUT NO DEVIATION WAS OBSERVED. SUMMARY: ONE SEALED (OVERWRAP) PACK WAS RECEIVED AT MANUFACTURING LOCATION FOR INVESTIGATION AS COMPLAINT SAMPLE. COMPLAINT SAMPLE WAS EVALUATED VISUALLY AGAINST RETAIN (CONTROL) SAMPLE. FINDINGS ARE AS FOLLOWS: PACKING MATERIAL FOR SEALING OF PRODUCT CODE NW3328 B8002 IS NUCREL TOP & NUCREL BOTTOM AS PER ETHICON EPID. HOWEVER, IN RECEIVED COMPLAINT SAMPLES SINGLE BARRIER FOLDER (SBF) HAS BEEN USED AS PACKING MATERIAL. THIS RECEIVED COMPLAINT SAMPLE IS CONFIRMED AS COUNTERFEIT PRODUCT. FURTHER THE ISSUE HAS BEEN ESCALATED TO BRAND PROTECTION TEAM TO INVESTIGATE THE CHANNEL THROUGH WHICH THIS PRODUCT IS ENTERED IN THE MARKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WAS SUSPECTED TO BE COUNTERFEIT IN 2021. THE PRODUCT WAS NOT USED ON THE PATIENT. UPON EVALUATION, IT WAS OBSERVED THAT THIS IS COUNTERFEIT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399677 NW3328 ETHILON 3-0 26MM 70CM C SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. B8002

    Patients

    Seq Age Sex Outcome Treatment
    1