BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PLUS¿ X100L PNG CLEAR

    MDR report key: 20734341 · Received November 20, 2024

    Report

    Report Number
    3009081593-2024-00036
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    November 4, 2024
    Report Date
    November 28, 2024
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 #: 2181073. D4. MEDICAL DEVICE EXPIRATION DATE: 31MAY2027. H4. DEVICE MANUFACTURE DATE: 30JUN2022. D4. MEDICAL DEVICE LOT #: 1165711. D4. MEDICAL DEVICE EXPIRATION DATE: 31MAY2026. H4. DEVICE MANUFACTURE DATE: 14JUN2021. D4. MEDICAL DEVICE LOT #: 3213452. D4. MEDICAL DEVICE EXPIRATION DATE: 31JUL2028. H4. DEVICE MANUFACTURE DATE: 01AUG2023. 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: UNCONFIRMED: NO SAMPLE/EVIDENCE PROVIDED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRASAFE PLUS¿ X100L PNG CLEAR SAFETY SYSTEM WAS ACTIVATED BEFORE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿WE HAD 3 BUVIDAL INJECTIONS THAT HAD A FAULTY SPRING (THE NEEDLE DID NOT RETRACT BACK AFTER THE DOSE WAS GIVEN) AT (B)(6).¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRASAFE PLUS¿ X100L PNG CLEAR SAFETY SYSTEM WAS ACTIVATED BEFORE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿WE HAD 3 BUVIDAL INJECTIONS THAT HAD A FAULTY SPRING (THE NEEDLE DID NOT RETRACT BACK AFTER THE DOSE WAS GIVEN) AT XXXX.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2431841 BD ULTRASAFE PLUS¿ X100L PNG CLEAR PISTON SYRINGE FMF BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown