BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SENSI-DISC¿ PIPERACILLIN/TAZOBACTAM - 100/10 ¿G

    MDR report key: 19173661 · Received April 24, 2024

    Report

    Report Number
    2647876-2024-00067
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    March 28, 2024
    Report Date
    June 19, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    JTN
    UDI-DI
    00382902316916
    PMA / PMN Number
    K940359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO BREAKPOINTS LISTED IN THE PACKAGE INSERT (PI) FOR PIPERACILLIN/TAZOBACTAM CATALOG 231691 (BATCH NUMBER NOT RECEIVED) ARE ALIGNED WITH CLSI M100:ED30 INSTEAD OF THE M100:ED33. THE INVESTIGATION REQUIRED TO EVALUATE PRODUCT INSERT AND INFORMATION SENT BY CUSTOMER. INFORMATION SENT BY CUSTOMER (PHOTO FROM PRODUCT INSERT SECTION AND CLSI INFORMATION) WERE EVALUATED. IT WAS IDENTIFIED THAT PRODUCT INSERT REQUIRED REVISION. COMPLAINT IS CONFIRMED. AS A CORRECTIVE ACTION PRODUCT INSERT WAS SUBMITTED FOR REVISION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Additional Manufacturer Narrative · 0

    H3. 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 THE PRODUCT INSERT FOR BD BBL¿ SENSI-DISC¿ PIPERACILLIN/TAZOBACTAM - 100/10 G CONTAINED INCORRECT BREAKPOINT INFORMATION FOR PIPERACILLIN/TAZOBACTAM. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRODUCT INSERT FOR BD BBL¿ SENSI-DISC¿ PIPERACILLIN/TAZOBACTAM - 100/10 G CONTAINED INCORRECT BREAKPOINT INFORMATION FOR PIPERACILLIN/TAZOBACTAM. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273521 BD BBL¿ SENSI-DISC¿ PIPERACILLIN/TAZOBACTAM - 100/10 ¿G SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL JTN BECTON DICKINSON CARIBE LTD. UNKNOWN 00382902316916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown