BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    MDR report key: 9126069 · Received September 26, 2019

    Report

    Report Number
    3001741852-2019-00059
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    August 12, 2019
    Report Date
    September 25, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    MEG
    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 · 1

    PMA/510(K)#: K011369, K060743, K122558. INVESTIGATION SUMMARY: UNCONFIRMED, NO SAMPLE RECEIVED INVESTIGATION CONCLUSION: 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 ROOT CAUSE DESCRIPTION: A FULL ROOT CAUSE ANALYSIS COULD NOT BE CONDUCTED WITH THE AVAILABLE INFORMATION AND IS CLOSED WITHOUT A CONCLUSION. UNTIL SAMPLES ARE AVAILABLE NO FURTHER INVESTIGATION WILL BE CARRIED OUT. BATCH RECORD REVIEW DID NOT INDICATE OF ANY INCIDENT IN RELATION TO THE PROBLEM STATEMENT. BATCH WAS RELEASED IN ACCORDANCE TO THE ACCEPTABLE CRITERIA. COMPLAINT COULD POTENTIALLY BE RELATED TO A LOOSE PLUNGER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ULTRASAFE X100L PR PLUM SSL NVS STEIN EXPERIENCED A PLUNGER THAT WAS BROKEN/LOOSE/FALLS OUT PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER DETACHED FROM SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920504 ULTRASAFE X100L PR PLUM SSL NVS STEIN NEEDLE GUARD MEG BECTON DICKINSON 1712674

    Patients

    Seq Age Sex Outcome Treatment
    1 Other