BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 5/0 (1) 70CM HR17 (M).RCP

    MDR report key: 8875938 · Received August 8, 2019

    Report

    Report Number
    3003639970-2019-00596
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 25, 2019
    Report Date
    September 17, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    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 · 0

    MANUFACTURING SITE EVALUATION: ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH, THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 18 CLOSED SAMPLES AND 1 OPEN SAMPLE (UNUSED) WITH THE NEEDLE DETACHED FROM THE THREAD (THREAD IS STILL WOUND ON THE PACK). TIGHTNESS TEST TO THE CLOSED 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 FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). 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: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED.

    Additional Manufacturer Narrative · 1

    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. K011375. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE LAID LOOSE IN THE PACKAGE. THE REPORTER INDICATED THAT NEEDLE LAY LOOSE IN THE PACKAGE, IT WAS NOT MOUNTING INSIDE THE PACKAGE / FIXATION. (NOT DETACHED FROM THE THREAD). THE EVENT OCCURRED PRE-OPERATIVELY. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670654 MONOSYN VIOLET 5/0 (1) 70CM HR17 (M).RCP SYNTHETIC ABSORBABLE MONOFILAR GAM B.BRAUN SURGICAL SA C2022003 117237V004

    Patients

    Seq Age Sex Outcome Treatment
    1