BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CHROMAGAR CANDIDA II 20 EA

    MDR report key: 12870017 · Received November 24, 2021

    Report

    Report Number
    2243072-2021-02819
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 8, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JSI
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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¿ CHROMAGAR¿ CANDIDA MEDIUM CATALOG NUMBER 254093 WHICH IS A CLASS 1, 510(K) EXEMPT DEVICE. INVESTIGATION SUMMARY: 252958-LOT# 1236518 THE DEFECT WAS NOT CONFIRMED BECAUSE THERE IS NO PICTURE AND RETURNED SAMPLE. WE WILL CONTINUE TO MONITOR THE TREND THIS ISSUE.

    Additional Manufacturer Narrative · 0

    IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(6)HAS BEEN LISTED IN SECTIONS AS (B)(6) IS AN (B)(6) MANUFACTURING SITE. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE U.S., BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BBL¿ CHROMAGAR¿ CANDIDA MEDIUM CATALOG NUMBER 254093 WHICH IS A CLASS 1, 510(K) EXEMPT DEVICE. INVESTIGATION SUMMARY: (B)(4) LOT# 1236518. THE DEFECT WAS NOT CONFIRMED BECAUSE THERE IS NO PICTURE AND RETURNED SAMPLE. WE WILL CONTINUE TO MONITOR THE TREND THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, ONE PLATE CHROMAGAR CANDIDA II 20 EA WAS MISSING LOT AND EXPIRATION DATE INFORMATION FROM THE LABEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ACCORDING TO THE CUSTOMER¿S REPORT, A LABEL IS HALF PEELED OFF AND THE LOT AND THE EXPIRATION DATE CANNOT BE SEEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, ONE PLATE CHROMAGAR CANDIDA II 20 EA WAS MISSING LOT AND EXPIRATION DATE INFORMATION FROM THE LABEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ACCORDING TO THE CUSTOMER¿S REPORT, A LABEL IS HALF PEELED OFF AND THE LOT AND THE EXPIRATION DATE CANNOT BE SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766085 PLATE CHROMAGAR CANDIDA II 20 EA CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON DICKINSON 1236518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown