BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 3/0 (2) 70CM HR22 (M)

    MDR report key: 12474195 · Received September 15, 2021

    Report

    Report Number
    3003639970-2021-00451
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Report Date
    November 18, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.U.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF BOTH CODE-BATCH. THERE ARE 12 UNITS BLOCKED IN OUR STOCK. WE HAVE RECEIVED A PICTURE SHOWING A POUCH LABELED AS NOVOSYN 2/0 70 CM FR26, CODE 0068415 AND BATCH 119452. ACCORDING TO THE CUSTOMER INFORMATION RECEIVED, THERE WERE 12 OF THESE POUCHES MIXED INSIDE A BOX OF SAFIL VIOLET 3/0 70CM HR22 C1048030 AND BATCH: 119451. THIS MISTAKE WAS PROBABLY CAUSED WHEN CONDITIONING THE PRODUCT IN BOXES IN THE MANUFACTURING LINE. AFTER INVESTIGATION, WE HAVE FOUND THAT BOTH PRODUCTS WERE PACKED ON THE SAME DAY. THEREFORE, WE ASSUME THAT THE CLEAN LINE OPERATION IN THE MANUFACTURING PROCESS WAS NOT PERFORMED CORRECTLY AND TWELVE UNITS OF THE REFERENCE (B)(4) WERE PACKED IN A BOX OF THE REFERENCE (B)(4) BY MISTAKE. TAKING INTO ACCOUNT THAT THERE ARE NO PREVIOUS COMPLAINTS OF BOTH CODES-BATCHES REGARDING THIS ISSUE, WE ASSUME AN ISOLATED AND ACCIDENTAL CASE, AFFECTING ONLY THIS BOX. 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: TAKING INTO ACCOUNT THAT THE RESULTS OF THE PICTURE RECEIVED DO NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE PICTURE RECEIVED. ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. 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.

    Additional Manufacturer Narrative · 1

    PMA/510K: K031286; REPORTED DEVICE NOT MARKETED IN THE US, HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE US. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH SAFIL SUTURE. THE CLIENT REPORTED THAT THERE WERE 12 UNITS OF NOVOSYN 2/0 70 CM FR26, CODE 0068415 AND BATCH 119452 MIXED IN A PACKAGE OF SAFIL VIOLET 3/0 (2) 70CM HR22, CODE C1048030 AND BATCH 119451. NO FURTHER INFORMATION HAS BEEN RECEIVED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370268 SAFIL VIOLET 3/0 (2) 70CM HR22 (M) SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A.U. C1048030 119451

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown