BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID BLACK 3/0 (2) 45CM DS19

    MDR report key: 8214930 · Received January 3, 2019

    Report

    Report Number
    3003639970-2019-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 10, 2018
    Report Date
    January 21, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012 G5: K990090 G5: 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. MANUFACTURING SITE EVALUATION: INVESTIGATION ONGOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: 1 OPEN POUCH. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE HAVE RECEIVED ONE OPEN SAMPLE FROM THE CUSTOMER WITH THE NEEDLE DETACHED FROM THE THREAD. WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. WE HAVE TESTED THE NEEDLE ATTACHMENT OF THE SAMPLES FROM STOCK AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 1.65 KGF IN AVERAGE AND 0.89 KGF IN MINIMUM (EP REQUIREMENTS: 0.69 KGF IN AVERAGE AND 0.35 KGF IN MINIMUM) REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: IN SPITE OF RECEIVING A DEFECTIVE SAMPLE, THE RESULTS OF THE SAMPLES FROM STOCK FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE WAS DETACHED FROM THE SUTURE PRIOR TO PATIENT USE. THIS WAS NOTED AS AN OUT-OF-THE-BOX OCCURRENCE, AND THERE WAS NO PATIENT HARM. IT WAS CONFIRMED THAT THERE WAS ONLY ONE PACK INVOLVED. NO FURTHER INFORMATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4203 SUPRAMID BLACK 3/0 (2) 45CM DS19 OTHER SUTURE GAR B.BRAUN SURGICAL SA C0712213 618255V030

    Patients

    Seq Age Sex Outcome Treatment
    1