BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO® HYPODERMIC NEEDLE-PRO® DEVICE

    MDR report key: 6439307 · Received March 28, 2017

    Report

    Report Number
    3012307300-2017-00779
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    February 8, 2017
    Report Date
    May 24, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    UDI-DI
    30351688046790
    PMA / PMN Number
    K923127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FURTHER CONCLUDED THAT THE RETURN SAMPLES FUNCTIONED AS DESIGNED AND NO FAULT WAS FOUND WITH THE RETURNED DEVICES. (CONCLUSION CODE) - CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    ONE BAG OF SEALED ORIGINAL KITS OF JELCO® HYPODERMIC NEEDLE-PRO® DEVICE WAS RETURNED FOR INVESTIGATION (PART NUMBER: 4286, LOT NUMBER: 3141033). A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES OR ANOMALIES RELEVANT TO THE REPORTED ISSUE. DURING FUNCTIONAL TESTING, A NEEDLE-PRO® WAS INSPECTED FOR DISCONNECT; THE SAMPLE STAYED CONNECTED DURING TESTING. A REVIEW OF ALL 49 PACKAGES WAS CONDUCTED AND IT WAS FOUND THAT ALL SAMPLES WERE SEALED PROPERLY. INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED ISSUE AND THEREFORE THE ROOT CAUSE WAS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A JELCO® HYPODERMIC NEEDLE-PRO® NEEDLE DETACHED FROM THE ORANGE SAFETY HOUSING DURING INJECTION ATTEMPT INTO THE GLUTEAL MUSCLE OF A PATIENT. THE DEPOT INJECTION WAS CONDUCTED BY A CERTIFIED PEDIATRIC NURSE AND THE ISSUE AROSE WHEN THE NURSE PRESSED ON THE SYRINGE PLUNGER. THE CONTENTS OF THE SYRINGE LEAKED ALL OVER THE PATIENT'S SKIN DUE TO THE ISSUE. THE NURSE HAD TO HOLD ONTO THE NEEDLE AND GENTLY REMOVE IT FROM THE PATIENT. ANOTHER NEEDLE WAS USED TO ADMINISTER THE MEDICATION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221513 JELCO® HYPODERMIC NEEDLE-PRO® DEVICE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. 3141033 30351688046790

    Patients

    Seq Age Sex Outcome Treatment
    1