BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SENSI-DISC¿ COLISTIN - 10 ¿G

    MDR report key: 17424585 · Received July 31, 2023

    Report

    Report Number
    2647876-2023-00090
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    JTN
    UDI-DI
    30382902312780
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO INCORRECT LABEL FOR COLISTIN CATALOG 231278 BATCH NO.: 8426744 WAS PERFORMED ON RETENTION SAMPLES. THE INVESTIGATION REQUIRED TO PERFORM VISUAL INSPECTION, BATCH RECORD REVIEW AND CUSTOMER PHOTO EVALUATION. NO DISCREPANCIES OBSERVED DURING RETENTION SAMPLES VISUAL INSPECTION. PHOTO RECEIVED FROM CUSTOMER WAS EVALUATED. IT WAS OBSERVED THAT PRODUCT WAS IDENTIFIED CORRECTLY. SINGLE CARTRIDGE IS IDENTIFIED WITH CATALOG 230749 WHILE PRODUCT PACKAGE (TEN PACK) IS IDENTIFIED WITH CATALOG 231278. CATALOGS 230749 AND 231278 ARE CORRECT FOR COLISTIN PRODUCT. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. COMPLAINT IS NOT CONFIRMED. 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 H.10.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED PRIOR TO USING BD BBL¿ SENSI-DISC¿ COLISTIN - 10 G, A BOX CONTAINED A DIFFERENT PRODUCT THAN WAS INDICATED BY THE LABEL. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ SENSI-DISC¿ COLISTIN - 10 ¿G, FIVE BOXES ARRIVED WITH INCORRECT LABEL INFORMATION. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER ORDERED BD 231278 DISC COLISTIN CL-10 HOWEVER THEY RECEIVED BD 230749 INSIDE THE BOX. SAME LOT NUMBER AND EXPIRY DATE HOWEVER THEY HAVE DIFFERENT BD ITEM/SKU NUMBER BASED ON THE BOX AND ITS ACTUAL PRODUCT INSIDE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ SENSI-DISC¿ COLISTIN - 10 G, FIVE BOXES ARRIVED WITH INCORRECT LABEL INFORMATION. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER ORDERED BD 231278 DISC COLISTIN CL-10 HOWEVER THEY RECEIVED BD 230749 INSIDE THE BOX. SAME LOT NUMBER AND EXPIRY DATE HOWEVER THEY HAVE DIFFERENT BD ITEM/SKU NUMBER BASED ON THE BOX AND ITS ACTUAL PRODUCT INSIDE."

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD BBL¿ SENSI-DISC¿ COLISTIN - 10 G, A BOX CONTAINED A DIFFERENT PRODUCT THAN WAS INDICATED BY THE LABEL. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908829 BD BBL¿ SENSI-DISC¿ COLISTIN - 10 ¿G SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL JTN BECTON DICKINSON CARIBE LTD. 2210171 30382902312780

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown