BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLE

    MDR report key: 18871224 · Received March 8, 2024

    Report

    Report Number
    3002682307-2024-00044
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    December 8, 2023
    Report Date
    March 7, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903032624
    PMA / PMN Number
    K043397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 230901. 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, FOUR (4) USED NEEDLE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE NEEDLES WERE MICROSCOPICALLY EXAMINED AND THE NEEDLES WERE FOUND CLOGGED WITH A VIAL MATERIAL AS WELL AS RESIDUAL MEDICATION. IT HAS BEEN DETERMINED THAT A CORING ISSUE WHICH RESULTED IN CLOGGED NEEDLE HAS TAKEN PLACE. MATERIAL 303262 WAS CREATED WITH A REGULAR CANNULA BEVEL IN CONTRAST TO MATERIAL 304622 WHICH HAD A SHORT BEVEL. MATERIAL 303262 SHOULD PENETRATE THE VIAL AT A 45-60 DEGREE ANGLE TO MINIMIZE THE RISK OF CORING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLE DID NOT ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: PROBLEM ENCOUNTERED: DIFFICULTY ASPIRATING CERTAIN PRODUCTS FOR SOME TIME NOW WITH THE PINK HYPODERMIC NEEDLES. AS IF THE HOLE WAS SMALLER. PROBLEM NOTED BY MANY IDES, AT FIRST THEY THOUGHT IT WAS AN ISOLATED CASE, BUT IT TURNED OUT TO BE VERY FREQUENT. IMPACT: WASTE OF TIME, PAIN WHEN HANDLING AND GASPILLAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156956 BD CONVENTIONAL NEEDLE NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 230901 00382903032624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown