BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13592965 · Received February 24, 2022

    Report

    Report Number
    1119779-2022-00296
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    January 25, 2022
    Report Date
    March 4, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BBL¿ HEMO (HAEMOPHILUS) ID QUAD (WITH GROWTH FACTORS) CATALOG NUMBER 297890 WITH 510K NUMBER K841304. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. THE RESULTS OF THIS EVALUATION HAVE NOT IDENTIFIED ANY NEW HAZARDS, NEW RISKS, OR SPECIFIC TRENDS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 2 BD BBL¿ HEMO (HAEMOPHILUS) ID QUAD (WITH GROWTH FACTORS) INSUFFICIENT GROWTH OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THIS IS A REPORT ABOUT INSUFFICIENT GROWTH. ACCORDING TO THE CUSTOMER'S INFORMATION, NO COLONY HAS GROWN FROM CELLS WHICH WERE IDENTIFIED BY A HEMO KIT BY ANOTHER COMPANY, IN #3 AND #4 IN A QUAD-FRACTIONATED AGAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 2 BD BBL¿ HEMO (HAEMOPHILUS) ID QUAD (WITH GROWTH FACTORS) INSUFFICIENT GROWTH OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT INSUFFICIENT GROWTH. ACCORDING TO THE CUSTOMER'S INFORMATION, NO COLONY HAS GROWN FROM CELLS WHICH WERE IDENTIFIED BY A HEMO KIT BY ANOTHER COMPANY, IN #3 AND #4 IN A QUAD-FRACTIONATED AGAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673929 BD BBL¿ HEMO (HAEMOPHILUS) ID QUAD (WITH GROWTH FACTORS) CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 1285912

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown