BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMILENE 3/0 (2) 90CM 2XHR26 CV

    MDR report key: 9369437 · Received November 25, 2019

    Report

    Report Number
    3003639970-2019-00813
    Event Type
    Injury
    Date Received
    November 25, 2019
    Report Date
    January 3, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    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

    INVESTIGATION: SAMPLES RECEIVED: 15 UNOPENED RACE-PACKS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED 15 CLOSED SAMPLES. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 1.72 KGF IN AVERAGE AND 1.62 KGF IN MINIMUM (EP REQUIREMENTS: 0.92 KGF IN AVERAGE AND 0.31 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. 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 · 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. K980703. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SUTURE BREAKS. THE REPORTER INDICATED THAT WHEN THE SUTURE IS SUTURED, THE SUTURE BREAKS. THE REPORTER STATED THIS EVENT OCCURRED PRIOR TO USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162461 PREMILENE 3/0 (2) 90CM 2XHR26 CV CARDIAC SUTURE GAW B.BRAUN SURGICAL SA C2090908 117395

    Patients

    Seq Age Sex Outcome Treatment
    1