BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE X100L PR CLEAR SSL NVS STEIN

    MDR report key: 8832826 · Received July 26, 2019

    Report

    Report Number
    3001741852-2019-00021
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 16, 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 · 1

    PMA / 510(K)#: K060743 OR K122558. INITIAL REPORTER PHONE #: UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER ROD SEPARATES WITH A BD ULTRASAFE X100L PR CLEAR SSL NVS STEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER ROD NOT ATTACHED TO SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623798 BD ULTRASAFE X100L PR CLEAR SSL NVS STEIN ANTISTICK SYRINGE MEG BECTON DICKINSON 1713590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other