BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN QUI UND 3/0(2) 70CM DRC18(M)DDP

    MDR report key: 9717665 · Received February 17, 2020

    Report

    Report Number
    3003639970-2020-00100
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 27, 2020
    Report Date
    February 17, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: 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. INVESTIGATION: SAMPLES RECEIVED: 1 UNOPENED POUCH. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED A CLOSED SAMPLE. THE SAMPLE HAS BEEN OPENED AND THE ALUMINUM POUCH (FIRST PACK) WAS NOT STUCK TO THE PEEL FOIL (SECOND PACK). THE PACK OPENED CORRECTLY. WITHOUT A DEFECTIVE SAMPLE, IN THIS CASE, A PROPER ANALYSIS CANNOT BE PERFORMED. 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: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. ACTIONS ON PRODUCT DISTRIBUTED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS AN ISSUE WITH PACKAGING STICKING. THE REPORTER INDICATED THAT AT THE OPENING OF TH OUTER PACKAGE, THE INNER PACKAGING REMAINS STUCK INSIDE. THE REPORTED EVENT WAS ENCOUNTERED ALL DAY. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181451 NOVOSYN QUI UND 3/0(2) 70CM DRC18(M)DDP SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C3046321 119402

    Patients

    Seq Age Sex Outcome Treatment
    1