BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M)

    MDR report key: 9453039 · Received December 11, 2019

    Report

    Report Number
    3003639970-2019-00867
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Report Date
    December 11, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. K111375. INVESTIGATION: SAMPLES RECEIVED: 1 OPEN POUCH. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED 3,636 UNITS IN THE MARKET. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED AN OPEN AND UNUSED SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD AND THE THREAD IS STILL WOUND ON THE PACK. HOWEVER, WITHOUT CLOSED SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. TAKING INTO ACCOUNT THAT THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH WE CONSIDER THAT THIS IS AN ISOLATED UNIT, BUT THE WHOLE BATCH IS CORRECT. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: IN SPITE OF RECEIVING A DEFECTIVE SAMPLE, WITHOUT CLOSED 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 ANALYSE 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 DETACHMENT BEFORE USE. THE REPORTER INDICATED THAT THE SEPARATION OF NEEDLES AND THREADS OCCUR AS SOON AS THE PACK IS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244156 MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M) SYNTHETIC ABSORBABLE MONOFILAR GAM B.BRAUN SURGICAL SA C0022007 118403

    Patients

    Seq Age Sex Outcome Treatment
    1