BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 3/0 (2) 90CM 2XHR22 CV

    MDR report key: 9176399 · Received October 10, 2019

    Report

    Report Number
    3003639970-2019-00688
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Report Date
    October 10, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. INVESTIGATION: SAMPLES RECEIVED: 1 UNOPENED RACE-PACK. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED 720 UNITS IN THE MARKET. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED A CLOSED SAMPLE. NEEDLE ATTACHMENT STRENGTH TEST RESULTS CONDUCTED WITH THE CLOSED SAMPLE RECEIVED HAVE VALUES THAT DO NOT FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA. 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: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. ACTIONS ON DISTRIBUTED PRODUCT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE DETACHED. THE REPORTER INDICATED THAT DURING PREPARATION THE NEEDLE DETACHED. PER THE REPORTER, A COUPLE OF TIMES DURING A SURGICAL PROCEDURE THE NEEDLE DETACHED DURING SUTURING ON A PATIENT. THERE WAS NO PATIENT INJURY OR HARM. PATIENT INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969321 PREMILENE 3/0 (2) 90CM 2XHR22 CV CARDIAC SUTURE GAW B.BRAUN SURGICAL SA C2090977 118193

    Patients

    Seq Age Sex Outcome Treatment
    1