BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL SENSI-DISC CEFOXITIN - 30 G

    MDR report key: 12095126 · Received June 30, 2021

    Report

    Report Number
    3008352382-2021-00170
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 2, 2021
    Report Date
    September 2, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    JTN
    UDI-DI
    30382902315910
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION FOR CEFOXITIN BATCH NO.: 0029199 WAS PERFORMED ON RETENTION SAMPLES. RETURNED GOODS WERE NOT RECEIVED. CATALOG 231591 BELONGS TO FOX-30. THE INVESTIGATION REQUIRED TO PERFORM VISUAL INSPECTION, AND BATCH RECORD REVIEW. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MIX OF PRODUCT BD BBL¿ SENSI-DISC¿ CEFOXITIN - 30 ¿G, PACKAGING IS FOR PART# 231591, HOWEVER, THE CARTRIDGES WERE PART# 231590. PRODUCT WAS USED, HOWEVER, THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGING WITH PRODUCT 231591 - CARTRIDGES WITH 231590 INSIDE; 5 X À 10 CARTRIDGES. PRODUCT USED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THERE WAS A MIX OF PRODUCT BD BBL¿ SENSI-DISC¿ CEFOXITIN - 30 G, PACKAGING IS FOR PART# 231591, HOWEVER, THE CARTRIDGES WERE PART# 231590. PRODUCT WAS USED, HOWEVER, THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGING WITH PRODUCT 231591 - CARTRIDGES WITH 231590 INSIDE; 5 X À 10 CARTRIDGES, PRODUCT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988260 BD BBL SENSI-DISC CEFOXITIN - 30 G SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL JTN BECTON DICKINSON CARIBE LTD. 231591 0029199 30382902315910

    Patients

    Seq Age Sex Outcome Treatment
    1