BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIT CRYSTAL GP ID

    MDR report key: 12849251 · Received November 19, 2021

    Report

    Report Number
    1119779-2021-01868
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 22, 2021
    Report Date
    March 21, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LQL
    PMA / PMN Number
    K961968
    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: THIS COMPLAINT IS FOR A LEAKING BASE OF CRYSTAL GP ID KIT (24514035) BATCH NUMBER UNKNOWN. NO PHOTOS OR PRODUCT RETURNS WERE PROVIDED FOR INVESTIGATION. DUE TO THE BATCH NUMBER BEING UNKNOWN, NO RETENTION INVESTIGATION COULD BE COMPLETED AND THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATION COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. A REVIEW OF COMPLAINTS COULD NOT BE COMPLETED AS THE BATCH NUMBER IS UNKNOWN. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. 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. 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 (B)(6) POSITIVE ID SYSTEM CATALOG NUMBER 245140 WHICH HAS 510K NUMBER (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD KIT CRYSTAL GP ID A PATIENT SAMPLE LEAK WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " ACCORDING TO THE CUSTOMER¿S REPORT, WHEN BACTERIAL LIQUID IS POURED ONTO THE BASE, THE LIQUID LEAKS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD KIT (B)(6) A PATIENT SAMPLE LEAK WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER¿S REPORT, WHEN BACTERIAL LIQUID IS POURED ONTO THE BASE, THE LIQUID LEAKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746687 BD KIT CRYSTAL GP ID GRAM POSITIVE IDENTIFICATION PANEL LQL BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown