BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RODAC SNAP LID TRYPTICASE SOY AGAR (TSA) W LECITHIN & POLYSORBATE 80

    MDR report key: 11275936 · Received February 3, 2021

    Report

    Report Number
    1119779-2021-00239
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 12, 2021
    Report Date
    February 10, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 1119779-2021-00239 WAS SENT IN ERROR. THIS PRODUCT IS NOT A MEDICAL DEVICE, THEREFORE, IT IS NOT CONSIDERED TO BE A REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD RODAC¿ SNAP LID TRYPTICASE¿ SOY AGAR (TSA) W LECITHIN & POLYSORBATE 80 THE LABEL ON PLATES WERE MISSING FIRST 2 DIGITS OF LOT NUMBER. THIS OCCURRED WITH 6 PLATES, THE PATIENT IMPACT WAS NOT REPORTED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD RODAC¿ SNAP LID TRYPTICASE¿ SOY AGAR (TSA) W LECITHIN & POLYSORBATE 80 THE LABEL ON PLATES WERE MISSING FIRST 2 DIGITS OF LOT NUMBER. THIS OCCURRED WITH 6 PLATES, THE PATIENT IMPACT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173532 BD RODAC SNAP LID TRYPTICASE SOY AGAR (TSA) W LECITHIN & POLYSORBATE 80 NA JSG BECTON, DICKINSON & CO. (SPARKS) 0254281

    Patients

    Seq Age Sex Outcome Treatment
    1