BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 3/0 (2) 10X60CM

    MDR report key: 7591496 · Received June 12, 2018

    Report

    Report Number
    3003639970-2018-00343
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Report Date
    October 31, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012 MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: NONE, PICTURES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS REFERENCE-BATCH. WE MANUFACTURED (B)(4) UNITS OF THIS CODE-BATCH AND DISTRIBUTED TO GULF MEDICAL CO. LTD. THERE ARE NO UNITS IN OUR STOCK. WE HAVE ONLY RECEIVED A PICTURE OF THE FRONT LABEL OF THE BOX THAT CORRESPONDS TO THE CODE-BATCH C0058182-117286 (NOVOSYN VIOLET 3/0(2) 10X60CM) AND A PICTURE OF THE PRODUCT INSIDE THE BOX THAT CORRESPONDS TO THE CODE-BATCH C0068766-117174 (NOVOSYN VIOLET 3/0 (2) 70CM HR20 (M)). ACCORDING TO THE INFORMATION RECEIVED, THE 36 UNITS CORRESPOND TO THE CODE-BATCH C0068766-117174. PRODUCTS TRACEABILITY HAS BEEN CHECKED AND THIS MIX-UP PROBABLY TOOK PLACE AT THE MOMENT OF PREPARING THE SHIPMENT IN THE WAREHOUSE, A BOX THAT CONTAINED (B)(4) UNITS OF THE CODE-BATCH C0068766-117174 WAS LABELLED WITH THE CODE-BATCH C0058182-117286 BY MISTAKE AND WAS SHIPPED TO GULF MEDICAL CO. LTD. HOWEVER, WITHOUT SAMPLES OR BACK LABEL OF THE BOX A PROPER ANALYSIS CANNOT BE PERFORMED. TAKING INTO ACCOUNT THE PICTURES RECEIVED, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED. NEVERTHELESS, IF WE RECEIVE THE BACK LABEL OF THE BOX OR THE INVOLVED BOX, WE WILL RE-OPEN THE CASE TO INVESTIGATE IT. FINAL CONCLUSION: WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED. CORRECTIVE/PREVENTIVE ACTIONS: THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINTS: SAUDI ARABIA. IT WAS REPORTED THAT WRONG PRODUCT WAS INSIDE THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435919 NOVOSYN VIOLET 3/0 (2) 10X60CM SUTURES GAM B.BRAUN SURGICAL SA C0058182 117286

    Patients

    Seq Age Sex Outcome Treatment
    1 Other