BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO® HYPODERMIC NEEDLE-PRO® DEVICE

    MDR report key: 6371918 · Received March 2, 2017

    Report

    Report Number
    3012307300-2017-00607
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Date of Event
    February 2, 2017
    Report Date
    March 2, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    UDI-DI
    30351688046851
    PMA / PMN Number
    K923127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT TWO DEVICES CONTRIBUTED TO TWO REPORTED EVENTS (ONE DEVICE PER EVENT). THE CUSTOMER RETURNED TWENTY DEVICES FOR EVALUATION. IT COULD NOT BE DETERMINED WHICH DEVICE WAS ASSOCIATED WITH WHICH REPORTED OCCURRENCE; THEREFORE, THE EVALUATION OF THE TWENTY RETURNED DEVICES WILL BE USED FOR THE MEDWATCH. THE FOLLOWING MFR WERE SUBMITTED RELATED TO THE EVALUATION: 3012307300-2017-00608 AND 3012307300-2017-00607. TWENTY SEALED PACKAGES OF JELCO® HYPODERMIC NEEDLE-PRO® DEVICES WERE RETURNED FOR INVESTIGATION. THE RETURNED DEVICES WERE GROUPED INTO 4 DIFFERENT LOT NUMBER CATEGORIES WITH 5 DEVICES RETURNED FOR EACH LOT. THE RETURNED LOT NUMBERS WERE 2251214, 2846897, 3305727, AND 3315093. THE REPORTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE RETURNED DEVICES WERE REMOVED FROM ALL PACKAGING AND WERE VISUALLY EXAMINED WITH THE UNAIDED EYE. NO DISCONNECTION BETWEEN THE NEEDLE AND PRO OR OTHER VISIBLE NON-CONFORMITIES WERE OBSERVED. DURING FUNCTIONAL TESTING THE NEEDLES WERE PLACED ONTO THE PRO UNIT AND THE SHEATHS WERE REMOVED. THE DEVICES WERE THEN LEAKED TESTED AND NO LEAKS OR DETACHMENT OF THE NEEDLE COMPONENT FROM THE PRO SAFETY DEVICE WERE OBSERVED DURING TESTING. INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED ISSUE AND FOUND THAT THE DEVICES OPERATED AS INTENDED.

    Additional Manufacturer Narrative · 1

    POTENTIAL LOT NUMBERS: 2551214, 2846897, 3305727. POTENTIAL EXPIRATION DATES: 09/30/2018, 11/30/2019, 10/27/2021. POTENTIAL DEVICE MANUFACTURER'S DATES: 09/24/2013, 11/24/2014, 11/14/2016. 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 A JELCO® HYPODERMIC NEEDLE-PRO® NEEDLE WAS IN USE ON A PATIENT WHILE GETTING INJECTIONS IN BOTH LEGS WHEN THE NEEDLE DETACHED FROM THE HUB, BROKE OFF, AND REMAINED IN THE PATIENT'S LEG. THE NEEDLE WAS ATTACHED TO A PREFILLED SYRINGE VIA A LUER LOCK SYSTEM. THE NURSING STAFF MANUALLY REMOVED THE NEEDLE USING TWEEZERS. DUE TO THE INCIDENT, THE PATIENT HAD LOCAL TENDERNESS AT THE NEEDLE INJECTION SITE. NO PERMANENT INJURY WAS REPORTED. THE EVENT WAS CONSIDERED RESOLVED. SEE MFR: 3012307300-2017-00608.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156661 JELCO® HYPODERMIC NEEDLE-PRO® DEVICE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. 30351688046851

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR VACCINE SYRINGE