BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID BLACK 5/0 (1) 45CM DS16

    MDR report key: 6567594 · Received May 15, 2017

    Report

    Report Number
    3003639970-2017-00269
    Event Type
    Malfunction
    Date Received
    May 15, 2017
    Report Date
    June 22, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, (B)(4) MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). THE SUTURE IS NOT LIKE USUAL, IT TEARS AND EASILY AND SOMETIMES IS DIFFERENT IN COLOR (BLUE).

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: THERE ARE NO SAMPLES AVAILABLE. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME BATCH. WE MANUFACTURED AND DISTRIBUTED (B)(4) UNITS OF THIS 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. REMARKS: AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT, WHEN WORKING WITH SUTURE MATERIALS GREAT CARE MUST BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS TWEEZERS AND NEEDLEHOLDER, DOES NOT LEAD TO DAMAGE BY PINCHING AND KINKING. ON THE OTHER HAND, WE HAVE TESTED NEEDLES FROM STOCK FOR BENDING STRENGTH AND THE RESULTS FULFILL PRODUCT SPECIFICATIONS: 5.45 NXCM, 5.34 NXCM AND 5.46 NXCM IN MINIMUM. MINIMUM BENDING STRENGTH SPECIFICATION: >5.2 NXCM. FURTHERMORE, BENDING STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 5.26 NXCM, 5.52 NXCM AND 5.65 NXCM AND FULFILLED THE SPECIFICATIONS OF THE PRODUCT (MINIMUM BENDING STRENGTH SPECIFICATION: >5.2 NXCM) 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. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348280 SUPRAMID BLACK 5/0 (1) 45CM DS16 SUTURES GAR B.BRAUN SURGICAL SA C0712124 616473V030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other