BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 150 UL

    MDR report key: 8609288 · Received May 14, 2019

    Report

    Report Number
    1823260-2019-01809
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    April 22, 2019
    Report Date
    November 11, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JRC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER WAS CORRECTED. THE INVESTIGATION CONFIRMED THE CUSTOMER'S ALLEGATION. CUSTOMERS HAVE BEEN INFORMED VIA CUSTOMER NOTIFICATION. THE US IS NOT IMPACTED. THE AFFECTED PART IS USED ONLY ON THE H232 WHICH IS A DEVICE NOT MARKETED IN THE US.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF AN ISSUE WITH A ROCHE CARDIAC PIPETTE. THE CUSTOMER ALLEGED THE NEEDLE SEPARATED FROM THE SYRINGE BODY WHEN THE CAP ON THE END OF THE DEVICE WAS REMOVED. THE NEEDLE WAS FOUND ON A CHAIR. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE DEVICE WAS REQUESTED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401475 SYRINGE 150 UL MICRO PIPETTE JRC ROCHE DIAGNOSTICS SYRINGE 150 UL 10013157

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown