BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ UREASE TEST BROTH

    MDR report key: 16801217 · Received April 24, 2023

    Report

    Report Number
    1119779-2023-00468
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    March 31, 2023
    Report Date
    June 6, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSH
    UDI-DI
    30382902217191
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 1119779-2023-00468 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    D.3 COMMON DEVICE NAME: CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ UREASE TEST BROTH THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER REPORTED LOT#: 3039044 SHOWING NO REACTION AT ALL WHEN INOCULATED WITH PROTEUS SP. CUSTOMER REPORTS IN THE PAST THEY USED TO ORDER THE 10X CONCENTRATION TUBES (221098), BUT SINCE THEY DISCONTINUED THE PRODUCT, THEY GOT PRODUCT 221719 AS AN ALTERNATIVE. CUSTOMER REPORTS THEY HAVE AT LEAST RECEIVED ONE PREVIOUS LOT OF 221719 BEFORE ND IT REACTED NORMALLY, HOWEVER WHEN THEY CHANGED TO LOT#: 3039044 , THEY HAVE NOT GOTTEN ANY REACTION ON ANY OF THE TUBES. IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: LOT#: (B)(6). HAZARD, INJURY OR ERRONEOUS RESULTS? YES; HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS NO REACTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ UREASE TEST BROTH THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER REPORTED LOT#: 3039044 SHOWING NO REACTION AT ALL WHEN INOCULATED WITH PROTEUS SP. CUSTOMER REPORTS IN THE PAST THEY USED TO ORDER THE 10X CONCENTRATION TUBES (221098), BUT SINCE THEY DISCONTINUED THE PRODUCT, THEY GOT PRODUCT 221719 AS AN ALTERNATIVE. CUSTOMER REPORTS THEY HAVE AT LEAST RECEIVED ONE PREVIOUS LOT OF 221719 BEFORE ND IT REACTED NORMALLY, HOWEVER WHEN THEY CHANGED TO LOT#: 3039044 , THEY HAVE NOT GOTTEN ANY REACTION ON ANY OF THE TUBES. IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: LOT#: 3039044. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS NO REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210174 BD BBL¿ UREASE TEST BROTH SEE H.10 JSH BECTON, DICKINSON & CO. (SPARKS) 221719 3039044 30382902217191

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown