BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOLOK

    MDR report key: 5067039 · Received September 10, 2015

    Report

    Report Number
    8040409-2015-00001
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    June 26, 2015
    Report Date
    August 22, 2015
    Manufacturer
    HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. (HMD)
    Product Code
    FMI
    PMA / PMN Number
    K945225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEEDLE MANUFACTURING PROCESS INVOLVES DEBURRING, WASHING INNER NEEDLE TUBES UNDER HIGH PRESSURE WATER JETS, AND INNER CLEANING IS THEN VERIFIED. SUBSEQUENTLY THESE CANNULAS ARE EXAMINED UNDER MAGNIFYING VISION FOR ANY FOREIGN MATTER/PARTICLES IN THE INNER SIDE FO THE NEEDLE. WE HAVE EXAMINED THE RETAINED SAMPLES FROM THIS BATCH, IN-PROCESS VERIFICATION RECORDS, AND FINAL PRODUCT VERIFICATION RECORDS. WE HAVE NOT OBSERVED ANY PROBLEM OR PRESENCE OF FOREIGN PARTICLE (INCLUDING METALLIC BURR) IN THE NEEDLES NEITHER IN SAMPLES AND NOR IN RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT METAL DEBRIS WAS FOUND IN THE TIP OF THE NEEDLE. IT WAS ALSO REPORTED THIS CONDITION OCCURED FOUR TIMES IN THE SAME WEEK FROM THE SAME END-USER. THIS REPORTED MALFUNCTION OF THE DEVICE DID NOT OCCUR DURING THE TREATMENT OF A PATIENT. NO DEFECTIVE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600130 UNOLOK BLUNT FILL NEEDLE FMI HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. (HMD) 02463 16561M

    Patients

    Seq Age Sex Outcome Treatment
    1 0 HR Other