BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TAXO¿ TB NIACIN TEST STRIPS

    MDR report key: 17313008 · Received July 12, 2023

    Report

    Report Number
    1119779-2023-00770
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    July 6, 2023
    Report Date
    September 8, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JTO
    UDI-DI
    00382902317418
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO INCORRECT EIFU FOR STRIP TB NIACIN CATALOG 231741 WAS PERFORMED ON RETENTION SAMPLES. THE INVESTIGATION REQUIRED TO EVALUATE EIFU WEBSITE. EIFU WEBSITE WAS EVALUATED AND IT WAS OBSERVED THAT THE EIFU IS CORRECT IN THE SYSTEM. NO DISCREPANCIES OBSERVED. EVIDENCE PROVIDED BY CUSTOMER WAS EVALUATED. IT WAS OBSERVED THAT THE SYSTEM INCLUDED CATALOG 231741 AS PART OF PRODUCTS INCLUDED ON EIFU NO. 8800681JAA. CUSTOMER IS AWARE THAT IFU 8800681JAA CAN'T BE USED SINCE IT DID NOT MAKE REFERENCE TO CATALOG 231741. AS A CORRECTIVE ACTION EIFU WEBSITE WAS CORRECTED. THE BD LABELING TEAM HAS REVIEWED THE ISSUE AND CONFIRMED AN INCORRECT DOCUMENT WAS DISPLAYED ON THE EIFU SITE. A TECHNICAL ISSUE WITH THE DOCUMENT LINK WAS IDENTIFIED AS PART OF THIS COMPLAINT AND A CORRECTIVE AND PREVENTATIVE ACTION WAS INITIATED IN ORDER TO ENSURE THE ISSUE IS BEING ADDRESSED AND CORRECTED MOVING FORWARD. BD APOLOGIZES FOR ANY INCONVENIENCE THIS HAS CAUSED. THE BD EIFU SITE ALSO DIRECTS USERS TO CUSTOMER SERVICE IN THE EVENT AN ERROR IS IN PLACE WITH THE SITE. A COPY OF THE IFU CAN BE REQUESTED BY CONTACTING BD TECHNICAL SERVICES. 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

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ TAXO¿ TB NIACIN TEST STRIPS, THE INCORRECT IFU DOCUMENT IS LOADING ON THE EIFU WEBSITE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THAT THE INCORRECT DOCUMENT IS LOADING ON THE EIFU WEBSITE - INSTEAD THE TAXO P DISC DOCUMENT IS LOADING. TECHNICAL SERVICES IDENTIFIED A DISCREPANCY IN THE IFU RECORD. NO IMPACT TO PATIENTS OR CUSTOMERS WAS ASSOCIATED WITH THIS DISCREPANCY AT THIS TIME."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ TAXO¿ TB NIACIN TEST STRIPS, THE INCORRECT IFU DOCUMENT IS LOADING ON THE EIFU WEBSITE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THAT THE INCORRECT DOCUMENT IS LOADING ON THE EIFU WEBSITE - INSTEAD THE TAXO P DISC DOCUMENT IS LOADING. TECHNICAL SERVICES IDENTIFIED A DISCREPANCY IN THE IFU RECORD. NO IMPACT TO PATIENTS OR CUSTOMERS WAS ASSOCIATED WITH THIS DISCREPANCY AT THIS TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260618 BD BBL¿ TAXO¿ TB NIACIN TEST STRIPS DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION JTO BECTON DICKINSON & CO. (SPARKS) 231741 UNKNOWN 00382902317418

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown