BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 1 (4) 70CM HR40S (M)

    MDR report key: 9489641 · Received December 18, 2019

    Report

    Report Number
    3003639970-2019-00896
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Report Date
    January 13, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. THERE WERE 36 UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE THAT WERE REQUESTED FOR ANALYSIS. NO SAMPLES HAVE BEEN RECEIVED FROM THE CUSTOMER, HOWEVER 36 UNITS (1 BOX) FROM STOCK WERE REQUESTED FOR ANALYSIS. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES FROM STOCK AND THE RESULTS FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 8.20 KGF IN AVERAGE AND 7.80 KGF IN MINIMUM (EP REQUIREMENTS: 5.18 KGF IN AVERAGE AND 2.59 KGF IN MINIMUM). KNOT SECURITY CONTROL HAS BEEN CONDUCTED WITH THE SAMPLES FROM OUR STOCK AND THE RESULTS ARE INTO THE CURRENT RANGE FOR THIS THREAD AND SIZE. 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: NO SAMPLES WERE RECEIVED FROM CUSTOMER BUT SAMPLES RECEIVED FROM STOCK. ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FROM STOCK 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. 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

    PMA/510K: 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. K980704. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SLIPS EASILY WHEN KNOTTING. THE REPORTER INDICATED THAT ON (B)(6) 2019, DURING A SURGICAL PROCEDURE; SUTURING A BLOOD VESSEL LIGATION, THE SUTURE WAS SLIPPERY AND HARD TO TIE A KNOT. THERE WAS NO SURGICAL DELAY AS THE SUTURE WAS IMMEDIATELY REPLACED WITH ANOTHER SUTURE AND THE SURGERY CONTINUED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283209 SAFIL VIOLET 1 (4) 70CM HR40S (M) SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C1048057 119135

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR