BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM AGAR)

    MDR report key: 12817136 · Received November 15, 2021

    Report

    Report Number
    9680577-2021-00079
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 20, 2021
    Report Date
    November 22, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSO
    PMA / PMN Number
    K894216B
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. 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¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM AGAR) CATALOG NUMBER 221954 WHICH HAS 510K NUMBER K894216B.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT AGAINST HAEMOPHILUS TEST MEDIUM AGAR (HTM), CATALOG NUMBER 254058, LOT NUMBER 1257478 WITH RESPECT TO POOR GROWTH OF HAEMOPHILUS INFLUENZAE. EVENT DESCRIPTION: IT WAS REPORTED THAT HAEMOPHILUS INFLUENZAE SHOWED POOR GROWTH ON THE AFFECTED MEDIUM. THE PERFORMED CONTROL USING ATCC STRAINS SHOWED POOR GROWTH AS WELL. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. THERE ARE ADDITIONAL TWO COMPLAINTS FOR POOR GROWTH OF HAEMOPHILUS SP. STRAINS CURRENTLY UNDER INVESTIGATION. IN ADDITION, THERE ARE CURRENTLY A TOTAL OF SIX COMPLAINTS UNDER INVESTIGATION REGARDING THE SAME ISSUE UNDER INVESTIGATION. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. SAMPLE ANALYSIS: RETURN SAMPLES AND PICTURES WERE NOT PROVIDED BY THE CUSTOMER. RETAIN SAMPLES FOR BATCH 1257478 WERE ANALYZED. THE QC DEPARTMENT PERFORMING THE ANALYSIS COULD CONFIRM THE COMPLAINT FOR POOR GROWTH OF H. INFLUENZAE. EVALUATION RESULTS: SINCE THE BHR SHOWED NO DEVIATIONS WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. BECAUSE A COMPLAINT TREND COULD BE IDENTIFIED, BD HAS SET UP AN INTERNAL INVESTIGATION WHICH IS CURRENTLY ONGOING. A DEFINITE ROOT CAUSE IS NOT IDENTIFIED YET. INVESTIGATION CONCLUSION: BASED ON OUR EVALUATION WE CAN CONFIRM THIS COMPLAINT FOR POOR GROWTH OF H. INFLUENZAE. BD WILL CONTINUE TO MONITOR FOR COMPLAINTS REGARDING MATERIAL NUMBER 254058. WE WOULD SUGGEST TO SET ASIDE, AND NOT USE, ANY PREPARED PLATED MEDIA THAT DOES NOT MEET THE APPEARANCE SPECIFICATION AS IT IS DESCRIBED ON THE BD CERTIFICATE OF ANALYSIS. THIS IS CONSISTENT WITH INDUSTRY RECOMMENDATIONS FOR INSPECTION OF CULTURE MEDIA PRIOR TO USE (E.G. ¿GOOD PRACTICES FOR PHARMACEUTICAL MICROBIOLOGY LABORATORIES¿, WHO TECHNICAL REPORT SERIES, (B)(4) ¿MICROBIOLOGY BEST LABORATORY PRACTICES¿ THE UNITED STATES PHARMACOPEIA; AND THE DIFCO & BBL MANUAL).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM AGAR) THERE WAS A PERFORMANCE ISSUE RESULTING IN NO GROWTH. THIS WAS THE ONLY STATED OCCURRENCE. NO ADDITIONAL TESTING WAS MENTIONED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPDATE 10/25/2021: WAS THIS WITH PATIENT SAMPLES OR QC? PATIENT. IF PATIENT SAMPLES - NEED TO KNOW IF THERE WAS ANY ERRONEOUS RESULTS AND IF SO - WERE ANY REPORTED OUT ON THE PATIENTS. WERE THEY TREATED BASED ON THE ERRONEOUS RESULTS? NO ERRONEOUS RESULT REPORTED. DID THIS LOT WORK PREVIOUSLY? IT WAS FIRST TIME THIS CUSTOMER RECEIVES THIS LOT. HAEMOPHILUS FOR DISC DIFUSSION DOES NOT GROW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM AGAR) THERE WAS A PERFORMANCE ISSUE RESULTING IN NO GROWTH. THIS WAS THE ONLY STATED OCCURRENCE. NO ADDITIONAL TESTING WAS MENTIONED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPDATE 10/25/2021: WAS THIS WITH PATIENT SAMPLES OR QC? PATIENT. IF PATIENT SAMPLES - NEED TO KNOW IF THERE WAS ANY ERRONEOUS RESULTS AND IF SO - WERE ANY REPORTED OUT ON THE PATIENTS. WERE THEY TREATED BASED ON THE ERRONEOUS RESULTS? NO ERRONEOUS RESULT REPORTED. DID THIS LOT WORK PREVIOUSLY? IT WAS FIRST TIME THIS CUSTOMER RECEIVES THIS LOT. HAEMOPHILUS FOR DISC DIFFUSION DOES NOT GROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1710075 BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM AGAR) 2PREPARED MEDIA JSO BECTON DICKINSON GMBH 1257478

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown