BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PLUS¿ 2.25 ML PASSIVE NEEDLE GUARD

    MDR report key: 21148535 · Received January 14, 2025

    Report

    Report Number
    3009081593-2025-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    December 30, 2024
    Report Date
    January 29, 2025
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 1290951. D4. MEDICAL DEVICE EXPIRATION DATE: 30SEP2026. H4. DEVICE MANUFACTURE DATE: 17OCT2021. D4. MEDICAL DEVICE LOT #: 3150644. D4. MEDICAL DEVICE EXPIRATION DATE: 30APR2028. H4. DEVICE MANUFACTURE DATE: 30MAY2023. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BASED ON THE EVIDENCE PROVIDED, BDM-PS IS ABLE TO CONFIRM THE REPORTED CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRASAFE PLUS¿ 2.25 ML PASSIVE NEEDLE GUARD PRE-ACTIVATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE COMPLAINT DESCRIBES A PREMATURELY ACTIVATED NSD. IT WAS STATED: "AN INJECTION OF INKIREN SODIUM WAS SOLD AND THE PATIENT TOOK THE DRUG FOR INJECTION AND FOUND THE NEEDLE HAD SHRUNK INTO THE PROTECTIVE COVER, SO THE INJECTION COULD NOT BE PERFORMED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRASAFE PLUS¿ 2.25 ML PASSIVE NEEDLE GUARD PRE-ACTIVATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE COMPLAINT DESCRIBES A PREMATURELY ACTIVATED NSD. IT WAS STATED: "AN INJECTION OF INKIREN SODIUM WAS SOLD AND THE PATIENT TOOK THE DRUG FOR INJECTION AND FOUND THE NEEDLE HAD SHRUNK INTO THE PROTECTIVE COVER, SO THE INJECTION COULD NOT BE PERFORMED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898079 BD ULTRASAFE PLUS¿ 2.25 ML PASSIVE NEEDLE GUARD PISTON SYRINGE FMF BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown