BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO¿ PURPLE AGAR BASE

    MDR report key: 13419347 · Received February 1, 2022

    Report

    Report Number
    1119779-2022-00168
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    August 1, 2021
    Report Date
    February 9, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED LOT# 00063494 WAS NOT FOUND FOR THE REPORTED CATALOG# 222810. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER FURTHER REVIEW, IT WAS FOUND THAT THE PRODUCT USED IN THE EVENT IS FOR LAB USE ONLY AND NOT FOR PATIENT SAMPLES. THEREFORE, THIS COMPLAINT WILL BE CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DIFCO¿ PURPLE AGAR BASE HAD PERFORMANCE ISSUES. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PURPLE AGAR BASE THAT IS NOT PERFORMING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DIFCO¿ PURPLE AGAR BASE HAD PERFORMANCE ISSUES. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PURPLE AGAR BASE THAT IS NOT PERFORMING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212680 BD DIFCO¿ PURPLE AGAR BASE CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown