BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL SENSI-DISC OXACILLIN - 1 G

    MDR report key: 12110530 · Received July 2, 2021

    Report

    Report Number
    3008352382-2021-00173
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 7, 2021
    Report Date
    September 2, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    JTN
    UDI-DI
    30382902313190
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION FOR OXACILLIN BATCH NO.: 0121991 WAS PERFORMED ON RETENTION SAMPLES. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO PERFORM BAUER KIRBY TEST, VISUAL INSPECTION, AND BATCH RECORD REVIEW. RETENTION SAMPLES PERFORMED AS EXPECTED. REFER TO RESULTS BELOW. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. PHOTO RECEIVED WAS EVALUATED. CUSTOMER CLAIM COULD NOT BE CONFIRMED THROUGH PHOTO EVALUATION. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ SENSI-DISC¿ OXACILLIN - 1 G ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER WOULD LIKE TO COMPLAIN ABOUT BATCH: 0121991 OF OXACILLIN 1G CARTRIDGES. THE OXACILLIN IS RESISTANT TO STREPTOCOCCUS PNEUMONIAE ATCC 49619. [CUSTOMER] HAD ANOTHER BATCH (0092546) THERE AND THIS IS SENSITIVE. "

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BBL¿ SENSI-DISC¿ OXACILLIN - 1 G ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER WOULD LIKE TO COMPLAIN ABOUT BATCH: 0121991 OF OXACILLIN 1 G CARTRIDGES. THE OXACILLIN IS RESISTANT TO STREPTOCOCCUS PNEUMONIAE ATCC 49619. CUSTOMER HAD ANOTHER BATCH (0092546) THERE AND THIS IS SENSITIVE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008316 BD BBL SENSI-DISC OXACILLIN - 1 G SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL JTN BECTON DICKINSON CARIBE LTD. 231319 0121991 30382902313190

    Patients

    Seq Age Sex Outcome Treatment
    1