BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 1 (4) 75CM HRT37 (M)

    MDR report key: 5703151 · Received June 7, 2016

    Report

    Report Number
    2916714-2016-00426
    Event Type
    Malfunction
    Date Received
    June 7, 2016
    Report Date
    June 7, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    K980703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 16 UNOPENED RACEPACKS AND 1 OPENED. ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THIS CODE BATCH. MANUFACTURED (B)(4) UNITS OF THIS CODE BATCH, THERE ARE NO UNITS IN STOCK. RECEIVED 16 CLOSED SAMPLES AND 1 OPEN SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD, AND THE THREAD IS STILL WOUND ON THE PACK. TESTED THE NEEDLE ATTACHMENT OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS DO NOT FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED THE OEM REQUIREMENTS. FINAL CONCLUSION: COMPLAINT JUSTIFIED: TAKING INTO ACCOUNT THAT THE RESULTS OF CLOSED SAMPLES RECEIVED DO NOT FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). WE APOLOGISE FOR ANY INCONVENIENCE THAT THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: REPLACE THIS CODE/BATCH TO THE CUSTOMER OR A REFUND. CORRECTIVE/PREVENTIVE ACTIONS: THIS COMPLAINT WILL BE INCLUDED IN THE ANALYSIS OF TRENDING, AND CORRECTIVE ACTION WILL BE OPEN IF APPLIES.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: SPAIN. THE NEEDLES ARE DETACHED FROM THE SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358645 PREMILENE 1 (4) 75CM HRT37 (M) SUTURES GAW B.BRAUN SURGICAL SA C2090463 114193

    Patients

    Seq Age Sex Outcome Treatment
    1 Other