BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ RAPID UREA BROTH

    MDR report key: 12677548 · Received October 21, 2021

    Report

    Report Number
    1119779-2021-01699
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 24, 2021
    Report Date
    May 11, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSH
    UDI-DI
    30382902983300
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: MATERIAL 298330 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE SOLUTION IS THEN STERILE FILTERED AND DISPENSED INTO TUBES. THE TUBES ARE MANUALLY THE BATCH HISTORY RECORD REVIEW FOR BATCH 1072858 WAS SATISFACTORY AT TIME OF RELEASE AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FILLING, TORQUING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1072858 (10 VIALS) WERE AVAILABLE FOR INSPECTION. NO CONTAMINATION VISUAL DEFECTS WERE OBSERVED IN THE RETENTION SAMPLES. RETENTIONS WERE PERFORMANCE TESTED PER PROCEDURE. PERFORMANCE TESTING OF THE RETENTIONS WAS SATISFACTORY.

    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 WHILE USING BD BBL¿ RAPID UREA BROTH FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS INCREASED POSITIVITY THAT IS DISCREPANT WITH PATHOLOGY BIOPSY RESULTS WITH USE OF MEDIA ITEM 298330-BBL RAPID UREA BROTH. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ RAPID UREA BROTH FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS INCREASED POSITIVITY THAT IS DISCREPANT WITH PATHOLOGY BIOPSY RESULTS WITH USE OF MEDIA ITEM 298330-BBL RAPID UREA BROTH. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574214 BD BBL¿ RAPID UREA BROTH CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON, DICKINSON & CO. (SPARKS) 298330 1072858 30382902983300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown