BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN QUICK UNDY 3/0(2)70CM DS24(M)DDP

    MDR report key: 8147913 · Received December 10, 2018

    Report

    Report Number
    3003639970-2018-00771
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Report Date
    January 9, 2019
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AJ
    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 G5: K122734 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. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A POSTOPERATIVE SURGICAL SITE INFECTION. NOVOSYN SUTURE HAD BEEN USED IN A PROCEDURE ON AN UNKNOWN DATE. SOMETIME LATER, THERE WAS A POSTOPERATIVE INFECTION. LABORATORY RESULTS SHOWED BACILLUS SPP. DURING SURGERY, IT WAS ALSO NOTED THAT THE THREADS WERE BREAKING AND THE NEEDLES WERE BLUNT. FURTHER INFORMATION WAS NOT PROVIDED. THE REPORT ADDRESSES THE THREADS BREAKING. ASSOCIATED MEDWATCHES: 3003639970-2018-00744, 3003639970-2018-00772.

    Additional Manufacturer Narrative · 1

    ASSOCIATED REPORTS: 3003639970-2018-00772, 3003639970-2018-00771, 3003639970-2018-00744. SAMPLES RECEIVED: THERE ARE NO SAMPLES AVAILABLE. 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 STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO MAKE A DECISION. AS NO SAMPLES HAVE BEEN RECEIVED AND NO UNITS ARE AVAILABLE IN B. BRAUN SURGICAL, S.A. WE COULD ONLY REVIEW THE BATCH MANUFACTURING RECORD AND THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. STERILIZATION PROCESS WAS ALSO NORMAL AND THE RESULTS OF THE STERILIZATION CONTROL ARE CORRECT. THE AVERAGE PENETRATION RESULTS OF THE NEEDLES BEFORE RELEASING THE PRODUCT WERE 0.418N, 0.351N, 0.415N, 0.373N AND 0.389N AND FULFILLED THE PUNCTION STRENGTH SPECIFICATION: <0.480N). NOVOSYN QUICK BIOCOMPATIBILITY HAS BEEN TESTED IN SEVERAL EXPERIMENTS. IN SENSITIZATION AND IRRITATION TESTS THE HARMLESSNESS OF NOVOSYN QUICK WAS PROVED. NEVERTHELESS, THERE ARE RISKS (SIDE EFFECTS) MAY BE ASSOCIATED WITH THE USE OF NOVOSYN QUICK SUTURE, WHICH ARE TYPICAL FOR ANY (ABSORBABLE) SUTURE AND WHICH ARE MENTIONED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: "TRANSITORY LOCAL IRRITATION, TRANSIENT INFLAMMATORY FOREIGN BODY REACTION, ENHANCED BACTERIAL INFECTIVITY, WOUND DEHISCENCE, GRANULATION". FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985749 NOVOSYN QUICK UNDY 3/0(2)70CM DS24(M)DDP SYNTHETIC ABSORBABLE BRAIDED GAM B. BRAUN SURGICAL SA C3046235 118192

    Patients

    Seq Age Sex Outcome Treatment
    1 Other