BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 5/0 (1) 45CM DS12 (M)

    MDR report key: 15904378 · Received December 2, 2022

    Report

    Report Number
    3003639970-2022-00511
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    August 19, 2022
    Report Date
    December 2, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    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

    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. UNDER PMA/510(K) NUMBER: K031286 ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. TWO CASES RECEIVED FROM THE SAME END CUSTOMER IN TWO CONSECUTIVE DAYS. (B)(4). WITHOUT CLOSED SAMPLES AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. FURTHERMORE, KNOT PULL TENSILE STRENGTH RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 1.10 KGF IN AVERAGE AND 1.04 KGF IN MINIMUM AND FULFILLED THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA: 0.69 KGF IN AVERAGE AND 0.35 KGF IN MINIMUM. NEEDLE ATTACHMENT RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 0.64 KGF IN AVERAGE AND 0.48 KGF IN MINIMUM AND FULFILLED EP REQUIREMENTS: 0.23 KGF IN AVERAGE AND 0.11 KGF IN MINIMUM. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. 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. 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 AN ISSUE WITH SAFIL SUTURE. THE CLIENT REPORTED THAT DURING (B)(6) 2022, BRAUN SUTURE WAS EASILY BROKEN DURING THE SURGERY. ALSO, SEVERAL PACKETS OF SUTURE WERE FOUND TO BE SEPARATED AFTER OPENING SO NEW ABSORBABLE SURGICAL SUTURE WAS REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796586 SAFIL VIOLET 5/0 (1) 45CM DS12 (M) SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. C1048207 721113

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown