BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    MDR report key: 8926503 · Received August 23, 2019

    Report

    Report Number
    3001741852-2019-00034
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 4, 2019
    Manufacturer
    BECTON DICKINSON
    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

    INVESTIGATION: UNCONFIRMED, NO SAMPLE RECEIVED. BATCH RECORD REVIEW DID NOT INDICATE OF ANY INCIDENT IN RELATION TO THE PROBLEM STATEMENT. BATCH WAS RELEASED IN ACCORDANCE TO THE ACCEPTABLE CRITERIA. BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY THE CUSTOMER BUT NOT CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ULTRASAFE X100L PR PLUM SSL NVS STEIN EXPERIENCED A PLUNGER THAT WAS LOOSE/FELL OUT/SEPARATED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS PAST BOX HE SAID THAT HE PICKED UP THE SYRINGE AND THE PLUNGER POPPED OUT AND ALL OF THE MEDICATION CAME OUT OF IT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. PMA/510(K)#: K011369, K060743, K122558. 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 A PLUNGER THAT WAS LOOSE/FELL OUT/SEPARATED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS PAST BOX HE SAID THAT HE PICKED UP THE SYRINGE AND THE PLUNGER POPPED OUT AND ALL OF THE MEDICATION CAME OUT OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721955 ULTRASAFE X100L PR PLUM SSL NVS STEIN SYRINGE, ANTISTICK MEG BECTON DICKINSON 1753135

    Patients

    Seq Age Sex Outcome Treatment
    1 Other