BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15932166 · Received December 7, 2022

    Report

    Report Number
    1119779-2022-01465
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Date of Event
    November 16, 2022
    Report Date
    March 20, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2022-01465 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

    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 RODAC¿ SNAP LID TRYPTICASE¿ SOY AGAR (TSA) W LECITHIN & POLYSORBATE 80 THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED BIOLOGICAL CONTAMINATION FOR THE PRODUCT 215285. LOT#2182524 AND #2210907. NON-VIABLE GRAM-POSITIVE COCCI WERE IDENTIFIED BY CUSTOMER'S QC FOR BOTH BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD RODAC¿ SNAP LID TRYPTICASE¿ SOY AGAR (TSA) W LECITHIN & POLYSORBATE 80 THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED BIOLOGICAL CONTAMINATION FOR THE PRODUCT 215285. LOT#2182524 AND #2210907. NON-VIABLE GRAM-POSITIVE COCCI WERE IDENTIFIED BY CUSTOMER'S QC FOR BOTH BATCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469821 BD RODAC¿ SNAP LID TRYPTICASE¿ SOY AGAR (TSA) W LECITHIN & POLYSORBATE 80 NA JSG BECTON, DICKINSON & CO. (SPARKS) 2182524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown