BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO LUER ADAPTER

    MDR report key: 1654643 · Received April 5, 2010

    Report

    Report Number
    1056186-2010-00001
    Event Type
    Injury
    Date Received
    April 5, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 11, 2010
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FMI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL, DIMENSIONAL AND MECHANICAL TESTING PERFORMED ON SAME LOT OF PRODUCT. ALL RESULTS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010 APPROXIMATELY 7:15AM, AN EXPERIENCED PT CARE TECH ATTACHED A NIPRO LUER ADAPTER TO A VACCUTAINER. NEXT, THE PT CARE TECH ATTACHED THE LUER LOCK AND VACCUTAINER TO THE PT'S ARTERIAL PORT OF HER CATHETER AND PROCEEDED TO DRAW SAMPLES USING LAB TUBES. AFTER LABS WERE SUCCESSFULLY DRAWN, THE PT CARE TECH TRIED TO REMOVE THE LUER ADAPTER AND WAS UNABLE TO REMOVE IT. AFTER TWISTING THE LUER ADAPTER AND VACCUTAINER, THE LUER ADAPTER BROKE OFF INSIDE THE CATHETER. THE PT WAS TAKEN TO A VASCULAR ACCESS CENTER, BUT HAD TO BE TRANSFERRED TO A HOSP BECAUSE THE CATHETER HAD BEEN IN FOR SO MANY YEARS IT COULD NOT BE REPAIRED AT THE OUTPATIENT CLINIC. SINCE REPLACEMENT OF THE CATHETER, THE PT HAS BEEN DIALYZED, BUT ALSO READMITTED TO THE HOSP FOR OTHER REASONS NOT RELATING TO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO LUER ADAPTER LUER ADAPTER FMI NIPRO MEDICAL CORPORATION LM+20G 09I07A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization