BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP

    MDR report key: 11552583 · Received March 23, 2021

    Report

    Report Number
    3003639970-2021-00094
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Report Date
    May 21, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED CASES: 3003639970-2021-00081 AND 3003639970-2021-00095. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THREE CASES RECEIVED FROM THE SAME END CUSTOMER. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED 20 CLOSED SAMPLES. 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): 0.89 KGF IN AVERAGE AND 0.67 KGF IN MINIMUM (EP REQUIREMENTS: 0.46 KGF IN AVERAGE AND 0.23 KGF IN MINIMUM). 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. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. WE REGRET ANY INCONVENIENCE THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. 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.

    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. K170661 IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH NOVOSYN QUICK SUTURE. THE CLIENT REPORTED THAT THE THREAD BREAKS AT THE CRIMPING AREA DURING USE. THERE WERE NO CONSEQUENCES FOR THE PATIENT. INCRIMINATED SAMPLE NOT PRESERVED. NEW SAMPLE PRESERVED. THESE THREADS BROKE DURING 3 OPERATIONS WITH 3 DIFFERENT SURGEONS. THE AREA OF RUPTURE WAS LOCATED AT THE CRIMPING AREA. THE INCIDENT WAS RESOLVED BY CHANGING THE BATCH. PATIENT CONSEQUENCES : INCREASED RISK OF HAEMORRHAGE INCREASED RISK OF INFECTION SUTURING OF THE WOUND TO BE STARTED AGAIN, RESULTING IN A PROLONGATION OF THE OPERATION. RELATED CASES: 3003639970-2021-00081 AND 3003639970-2021-00095.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448141 NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. C3046420 120085

    Patients

    Seq Age Sex Outcome Treatment
    1