BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 150 UL

    MDR report key: 6607470 · Received June 2, 2017

    Report

    Report Number
    1823260-2017-01130
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    May 9, 2017
    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 · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 1

    INCLUDING THIS COMPLAINT, THERE HAVE BEEN 21 ISSUES OF THE SAME NATURE WITHIN THE PAST 2 YEARS FOR THE COMPLAINED PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY FOUND A DEFECTIVE ROCHE CARDIAC PIPETTE. WHEN WITHDRAWING THE NEEDLE OF THE DEVICE FROM A SAMPLE TUBE, THE NEEDLE CAME OFF FROM THE SYRINGE BODY OF THE DEVICE AND REMAINED EMBEDDED IN THE STOPPER OF THE SAMPLE TUBE. THE NEEDLE WAS PROTRUDING FROM THE STOPPER. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AS THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. A PRODUCTION FAILURE OR FAILURE FROM ANY OTHER SOURCE COULD NOT BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388142 SYRINGE 150 UL MICRO PIPETTE JRC ROCHE DIAGNOSTICS NA 70163137

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown