BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SENSI-DISC¿ LEVOFLOXACIN - 5 ¿G

    MDR report key: 16550464 · Received March 15, 2023

    Report

    Report Number
    1119779-2023-00290
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    March 6, 2023
    Report Date
    April 21, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTN
    UDI-DI
    30382902317068
    PMA / PMN Number
    K970212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY : A COMPLAINT INVESTIGATION DUE TO INCORRECT LABEL FOR LEVOFLOXACIN CATALOG 231706 BATCH 2091272 WAS PERFORMED ON RETENTION SAMPLES. THE INVESTIGATION REQUIRED TO PERFORM VISUAL INSPECTION, AND BATCH RECORD REVIEW. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. PRODUCT WAS CORRECTLY IDENTIFIED. BATCH RECORD REVIEW DID NOT SHOWED ANY EVIDENCE OF CUSTOMER CLAIM. PHOTO RECEIVED FROM CUSTOMER WAS EVALUATED. IT WAS OBSERVED THAT PRODUCT WAS CORRECTLY IDENTIFIED. CATALOG 231705 AND 231706 ARE CORRECT NUMBERS FOR LEVOFLOXACIN (LVX-5) PRODUCT. CATALOG 231706 ITS FOR TEN PACK PACKAGING AND CATALOG 231705 ITS FOR SINGLE PACK PACKAGING. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ SENSI-DISC¿ LEVOFLOXACIN - 5 GM THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. WHEN STAFF OF STORAGE CHECK PRODUCT TO DELIVER FOR CUSTOMER, THEY SAW INFORMATION ON THE LABEL OF BOX NOT MATCH WITH CONTENT OF THIS BOX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ SENSI-DISC¿ LEVOFLOXACIN - 5 ¿GM THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN STAFF OF STORAGE CHECK PRODUCT TO DELIVER FOR CUSTOMER, THEY SAW INFORMATION ON THE LABEL OF BOX NOT MATCH WITH CONTENT OF THIS BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037615 BD BBL¿ SENSI-DISC¿ LEVOFLOXACIN - 5 ¿G SEE H.10 JTN BECTON, DICKINSON & CO. (SPARKS) 231706 2091272 30382902317068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown