BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN QUICK UNDY 3/0(2)70CM HS23(M)DDP

    MDR report key: 10312394 · Received July 23, 2020

    Report

    Report Number
    3003639970-2020-00272
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 23, 2020
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    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 · 1

    K170661: 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.. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME REFERENCE-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 FROM THE CUSTOMER FOR ANALYSIS. WITHOUT ANY SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. AS NO SAMPLES OR UNITS ARE AVAILABLE IN STOCK, WE HAVE ONLY BEEN ABLE TO REVIEW THE BATCH MANUFACTURING RECORD OF THIS PRODUCT. THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. 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. ANYWAY, ACCORDING TO 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NOVOSYN QUICK SUTURE. THE CLIENT REPORTED THAT SUTURE THREAD DETACHED FROM NEEDLE DURING SUTURING LABIAL TEAR POST CHILDBIRTH. SUTURE TIED AND NEW SUTURE USED TO CONTINUE. THE TISSUE SUTURED WAS PERINEAL SUTURING POST CHILDBIRTH, SUTURE USED ON LABIA. INTERRUPTED SUTURE TECHNIQUE EMPLOYED. ADDITIONAL DATA HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777074 NOVOSYN QUICK UNDY 3/0(2)70CM HS23(M)DDP SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. C3046136 119196

    Patients

    Seq Age Sex Outcome Treatment
    1