BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG CLEAR NVS STEIN

    MDR report key: 8874373 · Received August 8, 2019

    Report

    Report Number
    3001741852-2019-00028
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    May 29, 2019
    Report Date
    August 20, 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 SUMMARY: BATCH RECORD REVIEW DID NOT INDICATE OF ANY INCIDENT IN RELATION TO THE PROBLEM STATEMENT. BATCH WAS RELEASED IN ACCORDANCE TO THE ACCEPTABLE CRITERIA. NO SAMPLE WAS RETURNED FOR EVALUATION. A FULL ROOT CAUSE ANALYSIS COULD NOT BE CONDUCTED WITH THE AVAILABLE INFORMATION AND IS CLOSED WITHOUT A CONCLUSION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE ULTRASAFE X100L PNG CLEAR NVS STEIN HAS BEEN FOUND EXPERIENCING TWO CASES OF SAFETY SHIELD FAILURE BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: "OBSERVING THAT BOTH SYRINGE CAPS WERE ALREADY RETRACTED INTO THE SYRINGES (NEEDLE AND CAP)."

    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 HAS BEEN REPORTED THAT THE ULTRASAFE X100L PNG CLEAR NVS STEIN HAS BEEN FOUND EXPERIENCING TWO CASES OF SAFETY SHIELD FAILURE BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: "OBSERVING THAT BOTH SYRINGE CAPS WERE ALREADY RETRACTED INTO THE SYRINGES (NEEDLE AND CAP)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670980 ULTRASAFE X100L PNG CLEAR NVS STEIN PISTON SYRINGE MEG BECTON DICKINSON 6189317

    Patients

    Seq Age Sex Outcome Treatment
    1 Other