BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN QUICK UNDY 3/0(2)70CM HR26(M)DDP

    MDR report key: 8727698 · Received June 24, 2019

    Report

    Report Number
    3003639970-2019-00492
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Report Date
    July 24, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: (B)(4) UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 12 CLOSED SAMPLES FOR ANALYSIS. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. DEGRADATION TEST (7 DAYS IN SÖRENSEN SOLUTION PH=7.4 AT 37ºC) HAS BEEN CONDUCTED WITH THE SAMPLES RECEIVED AND THE RESULTS FULFILL B. BRAUN SURGICAL (BBS) REQUIREMENTS:0.51 KGF IN MINIMUM AND 0.59 KGF IN MAXIMUM (BBS REQUIREMENTS: 0.23 KGF <XI<0.96 KGF). 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: ACCORDING TO THE RESULTS OF THE SAMPLES TESTED AND THE BATCH MANUFACTURING RECORD REVIEW, THE PRODUCT COMPLIES WITH OUR SPECIFICATIONS AND ALSO FULFILL USP/EP REQUIREMENTS. THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. 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.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012 G5: 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. K0122734 WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL B SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SUTURE BREAKS DOWN TOO QUICKLY. THE REPORTER INDICATED THAT THIS FACILITY USES NOVOSYN QUICK 3-0 FOR SUTURES TO THE PERINEAL SKIN AND SUPERFICIAL TISSUE IN THE LABIA AFTER VAGINAL BIRTHS. THE BIRTHING DEPARTMENT HAS EVALUATED AND HAS DETERMINED THAT 20% OF THE PATIENTS WITH SUTURE BREAKDOWN AFTER USING NOVOSYN QUICK 3-0 OCCUR AT 48-72 HOURS AFTER BIRTH. THE KNOT TYING TECHNIQUE IS OK, KNOTS ARE STILL STABLE AT FOLLOW-UP BUT THE SUTURE SEEMS TO HAVE DISAPPEAR/DISSOLVE TOO QUICKLY. THE FACILITY EVALUATED ALL 4000 PATIENTS WITH VAGINAL BIRTHS ANNUALLY. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED. ASSOCIATED MEDWATCHES: 3003639970-2019-00493, 3003639970-2019-00494.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520417 NOVOSYN QUICK UNDY 3/0(2)70CM HR26(M)DDP SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C3046041 118495

    Patients

    Seq Age Sex Outcome Treatment
    1