BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 2/0 (3) 75CM 2XGR75 (M)

    MDR report key: 6415042 · Received March 17, 2017

    Report

    Report Number
    3003639970-2017-00116
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Report Date
    April 18, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE THREAD DETACHED FROM THE NEEDLE.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 7 OPEN UNITS. ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THIS BATCH. MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) OF THIS BATCH. THERE ARE NO UNITS IN STOCK. RECEIVED SEVEN OPEN SAMPLES (REFERENCE WITH DOUBLE NEEDLE). CHECKED THE SAMPLES RECEIVED AND THE SEVEN HAVE AT LEAST ONE NEEDLE DETACHED FROM THE THREAD AND SOME THREADS ARE STILL WOUND ON THE PACK. ON THE OTHER HAND, THE NEEDLES OF THE OPEN SAMPLES RECEIVED HAVE BEEN TESTED FOR BENDING STRENGTH AND THE RESULTS FULFILL PRODUCT SPECIFICATIONS: THE 29.23 NXCM IN MINIMUM. MINIMUM BENDING STRENGTH SPECIFICATION: >28.6 NXCM. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL B.BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THE SAMPLES RECEIVED AND THAT THERE IS ONE PREVIOUS COMPLAINT OF THE SAME BATCH WHERE THE RESULTS DID NOT FULFILL SPECIFICATIONS REGARDING NEEDLE ATTACHMENT, WE CONCLUDE THAT THE COMPLAINT IS JUSTIFIED. CORRECTIVE/PREVENTIVE ACTIONS: WE OPENED A CORRECTIVE ACTION IN ORDER TO AVOID THIS KIND OF INCIDENTS IN THE FUTURE (AK200470097).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196590 PREMILENE 2/0 (3) 75CM 2XGR75 (M) SUTURES GAW B.BRAUN SURGICAL SA C0090797 114104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other