BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE

    MDR report key: 9763841 · Received February 27, 2020

    Report

    Report Number
    3009081593-2020-00023
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    December 17, 2019
    Report Date
    March 6, 2020
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW THIS COMPLAINT WILL BE CANCELLED AS THERE WAS NO PROBLEM WITH THE ULTRASAFE DEVICE. AS STATED BY PRODUCTION SITE, ULTRASAFE DEVICE CANNOT BE INVOLVED IN THE EVENT OF THIS COMPLAINT (BROKEN SYRINGE). SO THIS COMPLAINT SHOULD NOT HAVE BEEN OPENED. THUS, THE COMPLAINT WILL BE CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE WAS BROKEN. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST FROM SHOPPERS DRUG MART CALLED TO ADVISE THAT ONE SYRINGE DISPENSED TO PATIENT WAS BROKEN.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K011369, K122558. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE WAS BROKEN. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST FROM SHOPPERS DRUG MART CALLED TO ADVISE THAT ONE SYRINGE DISPENSED TO PATIENT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230878 BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 9059604

    Patients

    Seq Age Sex Outcome Treatment
    1 Other