BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO® HYPODERMIC NEEDLE-PRO® DEVICE

    MDR report key: 6753764 · Received July 31, 2017

    Report

    Report Number
    3012307300-2017-01618
    Event Type
    Malfunction
    Date Received
    July 31, 2017
    Date of Event
    June 5, 2017
    Report Date
    July 31, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    UDI-DI
    20351688046816
    PMA / PMN Number
    K923127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF A JELCO® HYPODERMIC NEEDLE-PRO® DEVICE DETACHED FROM THE HUB WHILE ADMINISTERING A SUB-CUT INJECTION. THE DEVICE WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. IT WAS NOTED THE DEVICE WAS ATTACHED TO THE SYRINGE "CLEANLY AND SECURELY". THE NEEDLE REMAINED IN THE PATIENT AFTER DETACHING FROM THE HUB. ENOUGH OF THE NEEDLE REMAINED PROJECTED ABOVE THE SKIN, AND THE NEEDLE WAS REMOVED BY HAND. NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534394 JELCO® HYPODERMIC NEEDLE-PRO® DEVICE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. 3134054 20351688046816

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR 2.5ML BD PLASTIPAK