BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 0(3,5)8X45CM HR40S TO(M)

    MDR report key: 8838897 · Received July 29, 2019

    Report

    Report Number
    3003639970-2019-00557
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Report Date
    August 2, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: 1 OPEN POUCH (IT IS MISSING THE PART OF THE ALUMINUM POUCH WHERE THE BATCH NUMBER IS). ANALYSIS AND RESULTS: THE BATCH NUMBER IS NOT KNOWN. NEVERTHELESS, WE HAVE RECEIVED THE POSSIBLE BATCH NUMBERS: 118371, 118404 AND 118412. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 138 UNITS OF THE BATCH 118371, 162 UNITS OF THE BATCH 118404 AND 102 UNITS OF THE BATCH 118412. THERE ARE NO UNITS IN STOCK NOR PREVIOUS COMPLAINTS OF THESE POSSIBLE CODE-BATCHES. REVIEWED THE BATCH MANUFACTURING RECORDS, THESE PRODUCTS HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL B. BRAUN SURGICAL REQUIREMENTS. WE HAVE RECEIVED ONE OPEN AND USED SAMPLE WITH 6 DETACHED NEEDLES AND 2 SUTURES WITH THE NEEDLE ATTACHED TO THE THREAD. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE 2 SUTURES AND THE RESULTS ARE: 2.271 KGF. 2.454 KGF. THESE VALUES DO NOT FULFIL THE REQUIREMENTS OF B. BRAUN SURGICAL FOR MAXIMUM (0.080 <XI<1.700 KGF). PROBABLY, CAUSED BY TOO STRENGTH APPLIED TO ATTACH THE THREAD TO THE NEEDLE IN THE MANUFACTURING PROCESS. REMARKS: WE HAVE INFORMED OF THIS CASE TO THE PERSONNEL INVOLVED. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE SAMPLE RECEIVED DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE FAILURE IN THE SAMPLE 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. YOU WILL RECEIVE A CREDIT NOTE FOR ONE BOX AS COMPENSATION. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    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. K980704. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEEDLE DETACHMENT IS TOO HARD. THE REPORTER INDICATED THAT THE NEEDLE IS HARD TO DETACH FROM THE THREAD. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631145 SAFIL VIOLET 0(3,5)8X45CM HR40S TO(M) SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA M1078116

    Patients

    Seq Age Sex Outcome Treatment
    1