BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO HYPODERMIC NEEDLE WITH NEEDLE-PRO SAFETY DEVICE

    MDR report key: 5464332 · Received February 26, 2016

    Report

    Report Number
    2183502-2016-00309
    Event Type
    Malfunction
    Date Received
    February 26, 2016
    Date of Event
    January 26, 2016
    Report Date
    February 26, 2016
    Manufacturer
    SMITHS MEDICAL, INC.,
    Product Code
    FMI
    PMA / PMN Number
    K923127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4) UNOPENED SAMPLES FROM LOT: 3055628 AND (B)(4) UNOPENED SAMPLE FROM LOT: 2802398 WERE RECEIVED FOR INVESTIGATION. VISUAL INSPECTION DID NOT REVEAL ANY VISIBLE DEFECTS OR ANOMALIES. ALL SAMPLES REMAINED ASSEMBLED UPON OPENING EACH PACKAGE. A SIMULATED USE TEST WAS PERFORMED ON THE SAMPLES. THE RETURNED SAMPLES WERE REMOVED FROM THEIR PACKAGES AND ASSEMBLED TO THE MATING LUER OF A SYRINGE. THE SAMPLES WERE ASSEMBLED ACCORDING TO IFU, WHEREBY A PUSH AND A TWISTING MOTION IS USED TO SEAT THE NEEDLE ONTO THE NEEDLE-PRO DEVICE. THE NEEDLE WAS INSERTED WITHIN AN ISOPRENE INJECTION SITE (SIMULATING THE PATIENT). THE PLUNGER OF THE SYRINGE WAS ADVANCED (SIMULATING INJECTION) AND THE ASSEMBLY WAS THEN DRAWN BACK REMOVING THE NEEDLE FROM THE "PATIENT". THE SAMPLES WERE OBSERVED FOR SIGNS OF DISCONNECT BETWEEN THE NEEDLE AND THE NEEDLE-PRO DEVICE OR THE NEEDLE-PRO DEVICE AND THE SYRINGE LUER. NO ISSUES WERE OBSERVED. ALL SAMPLES REMAINED ASSEMBLED AS INTENDED. BASED ON THE RESULTS OF THIS INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT DURING USE OF THE LISTED HYPODERMIC NEEDLE FOR PATIENT INJECTIONS, THE NEEDLE SEPARATED FROM THE SYRINGE. NO ADVERSE EFFECTS TO PATIENTS OR USERS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120183 JELCO HYPODERMIC NEEDLE WITH NEEDLE-PRO SAFETY DEVICE NEEDLE, HYPODERMIC FMI SMITHS MEDICAL, INC., NA 3055628

    Patients

    Seq Age Sex Outcome Treatment
    1