BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS VIOLET 4/0(1,5)4X45 HR22 TO(M)

    MDR report key: 9144809 · Received October 2, 2019

    Report

    Report Number
    3003639970-2019-00656
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Report Date
    October 2, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    NEW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, (B)(4) MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K031216. INVESTIGATION: SAMPLES RECEIVED: 36 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE (B)(4) UNITS IN OUR STOCK. WE HAVE RECEIVED 36 UNOPENED POUCHES FOR ANALYSIS. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE B. BRAUN SURGICAL (BBS): 0.143 KGF IN MINIMUM AND 1.329 KGF IN MAXIMUM (BBS REQUIREMENTS: 0.080 KGF IN MINIMUM AND 1.700 KGF IN MAXIMUM). 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: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. 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 THE NEEDLE DETACHES EASILY. THE REPORTER INDICATED THAT THE NEEDLE DETACHES TOO EASILY. THE REPORTER STATED THAT THIS HAS HAPPENED WITH TWO DIFFERENT LOTS. ADDITIONAL INFORMATION WAS NOT PROVIDED, HOWEVER, HAS BEEN REQUESTED. ASSOCIATED MEDWATCH: 3003639970-2019-00657.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939429 MONOPLUS VIOLET 4/0(1,5)4X45 HR22 TO(M) SYNTHETIC ABSORBABLE MONOFILAR NEW B.BRAUN SURGICAL SA C0024764 118274

    Patients

    Seq Age Sex Outcome Treatment
    1