BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ HEMO (HAEMOPHILUS) ID QUAD (WITH GROWTH FACTORS)

    MDR report key: 16035308 · Received December 22, 2022

    Report

    Report Number
    1119779-2022-01523
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    December 12, 2022
    Report Date
    January 31, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    297890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: 252386 #2298409. WE COULDN'T CONFIRM THIS ISSUE AS A REPORT BECAUSE NO PHOTO AND RETURNED SAMPLE. COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS LOT. AT THIS TIME. DHR DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY AND NO DEVIATIONS WERE OBSERVED. A VISUAL INSPECTION WAS PERFORMED ON 10 RETENTION SAMPLES OF THIS LOT. AS A RESULT, NO DEFECT WAS OBSERVED. THE ROOT CAUSE FOR THIS COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR THIS LOT. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    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 BD BBL¿ HEMO (HAEMOPHILUS) ID QUAD (WITH GROWTH FACTORS) GROWTH OCCURRED THAT SHOULD NOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, H. INFLUENZAE HAS GROWN ON Q-II, EVEN THOUGH IT IS NOT SUPPOSED TO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ HEMO (HAEMOPHILUS) ID QUAD (WITH GROWTH FACTORS) GROWTH OCCURRED THAT SHOULD NOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, H. INFLUENZAE HAS GROWN ON Q-II, EVEN THOUGH IT IS NOT SUPPOSED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632161 BD BBL¿ HEMO (HAEMOPHILUS) ID QUAD (WITH GROWTH FACTORS) CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 2298409

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown