BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    MDR report key: 8461928 · Received March 28, 2019

    Report

    Report Number
    3001741852-2019-00006
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    March 11, 2019
    Report Date
    April 16, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K011369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BATCH RECORD REVIEW DID NOT INDICATE OF ANY INCIDENT IN RELATION TO THE PROBLEM STATEMENT. BATCH WAS RELEASED IN ACCORDANCE TO THE ACCEPTABLE CRITERIA. A SAMPLE WAS NOT RETURNED SO THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    PER RECEIVED EMAIL, THE PMA/510(K)# HAS BEEN UPDATED. THE FOLLOWING INFORMATION HAS BEEN CORRECTED: PMA/510(K)#: K011369, K060743, K122558.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ULTRASAFE X100L PR PLUM SSL NVS STEIN EXPERIENCED LEAKAGE. THE CUSTOMER STATED, "I OPENED THE PACKAGE, AND WHEN I WENT TO TAKE SYRINGE OUT. I FELT MOVEMENT AND THE PLUNGER OUT AND IT FELL ON THE FLOOR. THE THING THAT KEEP THE PLUNGER IN THERE WAS NOT IN THERE. A LOT OF THE MEDICATION IS PUSHED OUT AND THE MEDICATION GOT ON THE FLOOR AND ON ME".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ULTRASAFE X100L PR PLUM SSL NVS STEIN EXPERIENCED LEAKAGE. THE CUSTOMER STATED, "I OPENED THE PACKAGE, AND WHEN I WENT TO TAKE SYRINGE OUT. I FELT MOVEMENT AND THE PLUNGER OUT AND IT FELL ON THE FLOOR. THE THING THAT KEEP THE PLUNGER IN THERE WAS NOT IN THERE. A LOT OF THE MEDICATION IS PUSHED OUT AND THE MEDICATION GOT ON THE FLOOR AND ON ME".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ULTRASAFE X100L PR PLUM SSL NVS STEIN EXPERIENCED LEAKAGE. THE CUSTOMER STATED, "I OPENED THE PACKAGE, AND WHEN I WENT TO TAKE SYRINGE OUT. I FELT MOVEMENT AND THE PLUNGER OUT AND IT FELL ON THE FLOOR. THE THING THAT KEEP THE PLUNGER IN THERE WAS NOT IN THERE. A LOT OF THE MEDICATION IS PUSHED OUT AND THE MEDICATION GOT ON THE FLOOR AND ON ME".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255846 ULTRASAFE X100L PR PLUM SSL NVS STEIN SYRINGE FMF BECTON DICKINSON 1703375

    Patients

    Seq Age Sex Outcome Treatment
    1 Other