BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 3/0(2)4X45CM HR22TO(M)

    MDR report key: 8761075 · Received July 3, 2019

    Report

    Report Number
    3003639970-2019-00499
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Report Date
    July 26, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: THERE ARE NO SAMPLES AVAILABLE FOR ANALYSIS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. NO SAMPLES HAVE BEEN RECEIVED FROM THE CUSTOMER. NEVERTHELESS, WE HAVE RECEIVED A PICTURE WHERE WE CAN SEE THAT THERE ARE ONLY 3 SUTURES INSTEAD OF 4 SUTURES INSIDE A POUCH, CAUSED BY A HUMAN MISTAKE DURING PRODUCTION PROCESS. THE PRODUCT SHOULD HAVE 4 SUTURES INSIDE. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE PRODUCT IN THE PICTURE RECEIVED DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE PICTURE RECEIVED. ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K122734. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NUMBER OF SUTURES WAS INCORRECT IN THE PACK. THE REPORTER INDICATED THAT DURING A SURGICAL PROCEDURE THE NURSE OPENED THE PACK AND FOUND THAT THERE WERE ONLY THREE NEEDLES AND THREE THREADS IN THE PACK. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552241 NOVOSYN VIOLET 3/0(2)4X45CM HR22TO(M) SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C0088730 718442

    Patients

    Seq Age Sex Outcome Treatment
    1