BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID BLACK 3/0 (2) 75CM DS19

    MDR report key: 16137005 · Received January 11, 2023

    Report

    Report Number
    3003639970-2022-00565
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 13, 2022
    Report Date
    January 11, 2023
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAR
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. K151165. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 2,268 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY CLOSED AND/OR DEFECTIVE SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. 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. NEEDLE PENETRATION STRENGTH RESULT CONDUCTED ON SAMPLES TESTED DURING PRODUCTION OF EACH NEEDLE RAW MATERIAL BATCH USED IN THIS PRODUCT WERE 0.428N AND 0.446N IN AVERAGE AND FULFILLED SPECIFICATIONS: < 0.480N IN AVERAGE. THESE NEEDLES CONTROLLED DURING THE CONTROL PRODUCTION HAVE CONFORMING PENETRATION PERFORMANCE. REMARKS: CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING SURGICAL NEEDLES. GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE HALF (1/2) OF THE DISTANCE FROM THE ATTACHMENT END TO THE POINT. GRASPING IN THE POINT AREA COULD IMPAIR THE PENETRATION PERFORMANCE AND CAUSE FRACTURE OF THE NEEDLE. GRASPING AT THE BUTT OR ATTACHMENT END COULD CAUSE BENDING OR BREAKAGE. 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 SUPRAMID SUTURE. THE CLIENT (VETERINARIAN) REPORTED THAT THE NEEDLE WAS BLUNT. NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333694 SUPRAMID BLACK 3/0 (2) 75CM DS19 OTHER SUTURE GAR B. BRAUN SURGICAL, S.A. C0714216 622141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown