BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN UNDYED 3/0 (2) 70CM DGMP19 RCP

    MDR report key: 8637467 · Received May 23, 2019

    Report

    Report Number
    3003639970-2019-00427
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Report Date
    May 23, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012. 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. MANUFACTURING SITE EVALUATION: ANALYSIS: WE HAVE RECEIVED 18 CLOSED SAMPLES. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH; THERE ARE NO UNITS IN OUR STOCK. 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). REVIEW OF THE BATCH MANUFACTURING RECORDS SHOWED THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. NEEDLE ATTACHMENT RESULTS BEFORE RELEASING THE PRODUCT WERE 0.95 KGF IN AVERAGE AND 0.53 KGF IN MINIMUM AND FULFILLED EP REQUIREMENTS. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EP/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE SUTURE. DURING USE, THE SUTURE AND NEEDLE DETACHED. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429921 MONOSYN UNDYED 3/0 (2) 70CM DGMP19 RCP SYNTHETIC ABSORBABLE MONOFILAR GAM B.BRAUN SURGICAL SA C2023701 118294V003

    Patients

    Seq Age Sex Outcome Treatment
    1