BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 16142349 · Received January 11, 2023

    Report

    Report Number
    3002682307-2022-00368
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 1, 2022
    Report Date
    February 7, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300400 AND LOT NUMBER 211109. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE THE CANNULA COMPONENT IS SHOWN DETACHED FROM THE HUB WITH A FEW SPOTS OF EPOXY RESIDUE ON THE CANNULA. EPOXY IS THE ADHESIVE USED TO JOIN THE CANNULA TO THE HUB. BASED ON THE INVESTIGATION RESULTS, IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED FROM AN INAPPROPRIATE DOSAGE OF EPOXY.

    Additional Manufacturer Narrative · 0

    DATE OF BIRTH: PATIENT¿S BIRTHDAY WAS NOT PROVIDED, (B)(6) 2013 WAS USED BASED ON AGE OF PATIENT. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE DISLODGED FROM THE STYLUS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE DISLODGED FROM THE STYLUS DURING VACCINATION WITH VACCINE LEAKING AND THE NEEDLE REMAINING IN THE ARM AFTER WITHDRAWAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE DISLODGED FROM THE STYLUS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE DISLODGED FROM THE STYLUS DURING VACCINATION WITH VACCINE LEAKING AND THE NEEDLE REMAINING IN THE ARM AFTER WITHDRAWAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178676 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 211109

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male