BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP

    MDR report key: 9531544 · Received December 30, 2019

    Report

    Report Number
    3003639970-2019-00936
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Report Date
    December 30, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. K012201. INVESTIGATION: SAMPLES RECEIVED: 18 SUTURES INSIDE A POT. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 30 UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED FROM THE CUSTOMER 18 USED SUTURES INSIDE A POT FOR ANALYSIS. HOWEVER, WITHOUT ANY CLOSED OR UNUSED SAMPLE THE NEEDLE PUNCTURE STRENGTH CANNOT BE PERFORMED. CHECKING THE NEEDLES OF THE USED SUTURES RECEIVED, WE HAVE DETECTED THAT THERE ARE SEVERAL MARKS OF A NEEDLE HOLDER OR SURGICAL INSTRUMENT NEAR NEEDLE TIPS, AS CAN BE SEEN IN ENCLOSED PICTURE. AS STATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: CARE SHOULD BE TAKEN TO AVOID DAMAGING THE NEEDLE WHEN USING THE SUTURE MATERIAL. ALWAYS GRASP THE NEEDLE IN A SECTION 1/3 TO 1/2 OF THE DISTANCE FROM THE FIBER ATTACHMENT END TO THE NEEDLEPOINT, NEVER AT THE END WHERE THE FIBER IS ATTACHED OR THE NEEDLEPOINT. GRASPING THE NEEDLE AT THE AREA OF ITS POINT COULD IMPAIR THE PENETRATION PERFORMANCE AND CAUSE A FRACTURE OF THE NEEDLE. GRASPING THE NEEDLE CLOSE TO THE FIBER ATTACHMENT END COULD CAUSE BENDING OR BREAKAGE. 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. FINAL CONCLUSION: IN SPITE OF RECEIVING USED SUTURES, WITHOUT CLOSED OR UNUSED SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE IS BLUNT. THE REPORTER INDICATED THAT DURING A MITRAL AND AORTIC VALVE CARDIAC PROCEDURE, IT WAS REPORTED THE NEEDLE WAS BLUNT. PER THE REPORTER, THE PATIENT DID NOT HAVE ARTERIOSCLEROSIS. THE PATIENT OUTCOME WAS GOOD. PATIENT INFORMATION IS NOT AVAILABLE. ASSOCIATED MEDWATCH: 3003639970-2019-00924.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324715 PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP CARDIAC SUTURE GAT B.BRAUN SURGICAL SA M0027067 619304V004

    Patients

    Seq Age Sex Outcome Treatment
    1