BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC BACTERIAL PANEL

    MDR report key: 17547477 · Received August 14, 2023

    Report

    Report Number
    3007420875-2023-00074
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    August 7, 2023
    Report Date
    September 20, 2023
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCI
    UDI-DI
    00382904429638
    PMA / PMN Number
    K140111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 3007420875-2023-00074 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    D.5. MEDICAL DEVICE TYPE: OOI, PCH. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD MAX¿ ENTERIC BACTERIAL PANEL, ONE KIT ARRIVED WITHOUT A LABEL. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PACKAGING IS NORMAL AND HAS NOT BEEN OPENED, BUT THERE ARE NO LABELS ON THE PACKAGING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD MAX¿ ENTERIC BACTERIAL PANEL, ONE KIT ARRIVED WITHOUT A LABEL. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PACKAGING IS NORMAL AND HAS NOT BEEN OPENED, BUT THERE ARE NO LABELS ON THE PACKAGING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963448 BD MAX¿ ENTERIC BACTERIAL PANEL GASTROINTESTINAL BACTERIAL PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 3052425 00382904429638

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown