BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PASSIVE¿ NEEDLE GUARD

    MDR report key: 20774439 · Received November 25, 2024

    Report

    Report Number
    3009081593-2024-00040
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 2, 2024
    Report Date
    November 29, 2024
    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

    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: CONFIRMED: REPORTED CONDITION WAS OBSERVED AT BDM-PS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRASAFE X100LG2XL PNG BLUE TINT ACTIVATED EARLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER,: THE PROTECTIVE CAP WAS STILL ON. THE PLUNGER WAS STILL OUTSIDE BUT CANNOT BE MOVED. SOLUTION IS STILL INSIDE THE FSP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRASAFE X100LG2XL PNG BLUE TINT ACTIVATED EARLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER,: THE PROTECTIVE CAP WAS STILL ON. THE PLUNGER WAS STILL OUTSIDE BUT CANNOT BE MOVED. SOLUTION IS STILL INSIDE THE FSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630601 BD ULTRASAFE PASSIVE¿ NEEDLE GUARD PISTON SYRINGE FMF BECTON DICKINSON HUNGARY KFT (BD) 2179770

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown