BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VIAL UVT 1 ML WITH BEADS

    MDR report key: 10312307 · Received July 23, 2020

    Report

    Report Number
    1119779-2020-00242
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    July 4, 2020
    Report Date
    January 28, 2021
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JSM
    PMA / PMN Number
    K042970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS CUSTOMER COMPLAINT IS NOT CONFIRMED. NO BATCH NUMBER WAS PROVIDED NOR WERE ANY SAMPLES RETURNED. A BATCH SPECIFIC INVESTIGATION CANNOT BE CONDUCTED. A REVIEW OF PAST COMPLAINTS FOR THIS PRODUCT DOES NOT INDICATE A CONFIRMED TREND ON THIS ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BLANK BD VIAL UVT 1 ML WITH BEADS TUBE, A FALSE POSITIVE RESULT WAS OBTAINED FOR N1 AND N2 IDT CDC ASSAY. N2 ALSO SHOWS POSITIVE WITH PATIENT SAMPLES.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BLANK BD VIAL UVT 1 ML WITH BEADS TUBE, A FALSE POSITIVE RESULT WAS OBTAINED FOR N1 AND N2 IDT CDC ASSAY. N2 ALSO SHOWS POSITIVE WITH PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782402 BD VIAL UVT 1 ML WITH BEADS TRANSPORT CULTURE MEDIUM JSM BECTON, DICKINSON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other