BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOLOK

    MDR report key: 5009793 · Received August 14, 2015

    Report

    Report Number
    1058382-2015-00002
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    June 26, 2015
    Report Date
    May 4, 2016
    Manufacturer
    HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. (HMD)
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CANNULA (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 OF THE NEEDLE. WE HAVE EXAMINED THE RETAINED SAMPLE OF THIS BATCH, IN PROCESS VERIFICATION RECORDS, AND FINAL PRODUCT VERIFICATION RECORDS. WE HAVE NOT OBSERVED ANY PROBLEM / PRESENCE OF FOREIGN PARTICLE (INCLUDING METALLIC BURR) IN THE NEEDLES NEITHER IN SAMPLES NOR IN RECORDS. THE MANUFACTURER LATER RECALLED THIS BATCH DUE TO REPORTS OF CORING OF RUBBER VIAL ENCLOSURES (REF. Z-0444-2016). THE MANUFACTURER WAS UNABLE TO ADDRESS THE INSTANCE OF CORING ON THE BLUNT FILL NEEDLE TO ITS SATISFACTION AND HAS DISCONTINUED THE PRODUCT CITING THE INABILITY TO MATCH THE CORING RATE OF THE MARKET LEADER. TESTS WERE BASED ON CLINICAL USE IN THE US MARKET USING RUBBER VILE CLOSURES USED IN THE US MARKET. NO OTHER REPORTS WERE RECEIVED OF METAL DEBRIS ASSOCIATED WITH THIS PRODUCT, AND METAL DEBRIS WAS NEVER CONFIRMED AS THE DEVICE(S) WAS/WERE NOT RETURNED TO THE MANUFACTURER FOR EXAMINATION. WE HAVE PROVIDED THE MOST RECENT INFORMATION AVAILABLE AT THIS TIME FOR THIS FOLLOW UP REPORT, AND CONSIDER THE REPORT CLOSED.

    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. THIS REPORTED MALFUNCTION FO THE DEVICE DID NOT OCCUR DURING THE TREATMENT OF A PATIENT. NO DEFECTIVE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

    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 OCCURRED FOUR TIMES IN THE SAME WEEK. 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. THE CANNULA (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/ PARTIALS IN THE INNER SIDE OF THE NEEDLE. WE HAVE EXAMINED THE RETAINED SAMPLES OF (THIS) BATCH, IN PROCESS VERIFICATION RECORDS AND FINAL PRODUCT VERIFICATION RECORDS. WE HAVE NOT OBSERVED ANY PROBLEM / PRESENCE OF FOREIGN PARTICLE (INCLUDING METALLIC BURR) IN THE NEEDLES NEITHER IN SAMPLES AND NOR IN RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537845 UNOLOK BLUNT FILL NEEDLE FMI HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. (HMD) 18G X 1.5'' 16561M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other