BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINALYSIS TRANSFER STRAW KIT WITH 8ML PLASTIC CONICAL BOTTOM TUBE, 16X100MM

    MDR report key: 7073704 · Received November 30, 2017

    Report

    Report Number
    1917413-2017-00288
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    January 26, 2016
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    KDT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #5093590. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH THE DEVICE TYPE CODE LISTED AS JSM. IT IS CORRECTED TO READ KDT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT URINALYSIS TRANSFER STRAW KIT WITH 8ML PLASTIC CONICAL BOTTOM TUBE, 16X100MM CAP STAYED IN BY THE NEEDLE WHEN PULLING OUT VIAL WITH SPECIMEN. THIS RESULTED IN URINE BEING SPILLED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852968 URINALYSIS TRANSFER STRAW KIT WITH 8ML PLASTIC CONICAL BOTTOM TUBE, 16X100MM URINE COLLECTION SET KDT BECTON, DICKINSON & CO. 5093590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other