BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 3/0 (2) 45CM HS21

    MDR report key: 9528530 · Received December 28, 2019

    Report

    Report Number
    3003639970-2019-00940
    Event Type
    Malfunction
    Date Received
    December 28, 2019
    Report Date
    December 28, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. K990089. INVESTIGATION: SAMPLES RECEIVED ONE OPEN POUCH. ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THE SAME CODE-BATCH REGARDING OTHER ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 6,480 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE OPEN SAMPLE WITH TWO DETACHED NEEDLES INSIDE A PLASTIC BAG. HOWEVER, WITHOUT A CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO MAKE A DECISION. REVIEWED THE BATCH MANUFACTURING RECORD OF THIS PRODUCT, AN INTERNAL NON-CONFORMITY WAS FOUND BUT IT WAS RELEASED INTO THE MARKET FULFILLING USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. NEEDLE ATTACHMENT STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 0.72 KGF IN AVERAGE AND 0.48 KGF IN MINIMUM AND FULFILLED THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP REQUIREMENTS: 0.69 KGF IN AVERAGE AND 0.35 KGF IN MINIMUM). FINAL CONCLUSION: IN SPITE OF RECEIVING A DEFECTIVE SAMPLE, WITHOUT CLOSED SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. 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 THE NEEDLE DETACHES. THE REPORTER INDICATED THAT THE THREAD TORE MORE OFTEN ON THE NEEDLE. MALFUNCTION FOUND BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323005 SILKAM BLACK 3/0 (2) 45CM HS21 OTHER SUTURE GAP B.BRAUN SURGICAL SA C0762261 619271V004

    Patients

    Seq Age Sex Outcome Treatment
    1