BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 3/0 (2) 75CM HR22

    MDR report key: 8837659 · Received July 29, 2019

    Report

    Report Number
    3003639970-2019-00561
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Report Date
    July 29, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. K990089. SAMPLES RECEIVED: 1 OPEN POUCH. 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 OUR STOCK. WE HAVE RECEIVED ONE OPEN AND UNUSED SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD (THREAD IS STILL WOUND ON THE PACK). HOWEVER, WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REVIEWED THE BATCH MANUFACTURING RECORDS, THE BATCH HAS AN INCIDENCE AND IT WAS RELEASED IN THE MARKET FULFILLING USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. NEEDLE ATTACHMENT STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 0.77 KGF IN AVERAGE AND 0.64 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 THE NEEDLE DETACHED FROM THE (WIRE) THREAD. THE REPORTER INDICATED THE NEEDLE DETACHED FROM THE SUTURE WIRE WHEN THE PACKAGE/ WALLET WAS OPENED. THE DEFECT WAS FOUND BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629075 SILKAM BLACK 3/0 (2) 75CM HR22 OTHER SUTURE GAP B.BRAUN SURGICAL SA C0760307 618212

    Patients

    Seq Age Sex Outcome Treatment
    1