BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL MGIT PANTA ANTIBIOTIC MIXTURE, LYOPHILIZED

    MDR report key: 11282173 · Received February 4, 2021

    Report

    Report Number
    1119779-2021-00204
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Date of Event
    January 12, 2021
    Report Date
    March 3, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    30382902451144
    PMA / PMN Number
    K954932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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# 1119779-2021-00204 WAS SENT IN ERROR. DURING INVESTIGATION IT WAS DISCOVERED THAT IT WASN'T AN ISSUE WITH THE PANTA VIAL, IT WAS THE SUPPLEMENT. THIS ISSUE WAS CAPTURED ON MFR REPORT# 1119779-2021-00205.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ MGIT¿ PANTA¿ ANTIBIOTIC MIXTURE, LYOPHILIZED FUNGAL CONTAMINATION WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TB LAB STAFF WENT TO RECONSTITUTE A VIAL OF PANTA LOT 0149921 WITH THE GROWTH SUPPLEMENT LOT 0149929 AND NOTED WHAT APPEARS TO BE A FUNGAL BALL OF CONTAMINATION THAT WAS IN THE LIQUID SUPPLEMENT AND WAS TRANSFERRED TO THE PANTA WHEN RECONSTITUTING IT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: PMA / 510(K)#: K974883. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ MGIT¿ PANTA¿ ANTIBIOTIC MIXTURE, LYOPHILIZED FUNGAL CONTAMINATION WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TB LAB STAFF WENT TO RECONSTITUTE A VIAL OF PANTA LOT 0149921 WITH THE GROWTH SUPPLEMENT LOT 0149929 AND NOTED WHAT APPEARS TO BE A FUNGAL BALL OF CONTAMINATION THAT WAS IN THE LIQUID SUPPLEMENT AND WAS TRANSFERRED TO THE PANTA WHEN RECONSTITUTING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178053 BD BBL MGIT PANTA ANTIBIOTIC MIXTURE, LYOPHILIZED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245114 UNKNOWN 30382902451144

    Patients

    Seq Age Sex Outcome Treatment
    1