BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ STAPHYLOSLIDE¿ LATEX TEST KIT, 100 TESTS

    MDR report key: 12084377 · Received June 29, 2021

    Report

    Report Number
    1119779-2021-01075
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 1, 2021
    Report Date
    January 24, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    GTN
    UDI-DI
    00382902409151
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS STATEMENT SERVES TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT 3007316 ON PRODUCT 240915 (KIT STAPHYLOSLIDE LATEX 100 TEST) LOT NUMBER C18976, WHERE IT WAS OBSERVED THAT THE TEST LATEX APPEARED TO HAVE AGGLUTINATION WITHOUT ANY TEST SAMPLE. COMPLAINT HISTORY REVIEW: A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS DOES NOT INDICATE A TREND ON THIS ISSUE. DEVICE HISTORY RECORD REVIEW: THE REVIEW OF THE DEVICE HISTORY RECORD DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY AND NO DEVIATIONS WERE NOTED. SAMPLE ANALYSIS: NO PHOTOS OR RETURNS WERE AVAILABLE. AN INSPECTION OF THE RETENTION SAMPLES DID NOT REPRODUCE THE NOTED DEFECT. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, NO DEFECT WAS OBSERVED. THERE IS NO SYSTEMIC FAILURE IN THE MANUFACTURING PROCESS AND THE RETENTION SAMPLES WERE SATISFACTORY. AS NO DEVIATIONS WERE OBSERVED IN THE INVESTIGATION, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO MONITOR FOR TRENDING. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED. NO FURTHER ACTIONS WILL BE TAKEN AS NO CONFIRMED TREND HAS BEEN IDENTIFIED. A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ STAPHYLOSLIDE¿ LATEX TEST KIT, 100 TESTS A FALSE POSITIVE RESULT WAS OBTAINED AND CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WOULD ALREADY BECOME POSITIVE WITHOUT SAMPLES AND INSIDE IT WOULD BE SOMEWHAT FLOCCULATED, NOTHING COULD BE READ. ".

    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¿ STAPHYLOSLIDE¿ LATEX TEST KIT, 100 TESTS A FALSE POSITIVE RESULT WAS OBTAINED AND CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WOULD ALREADY BECOME POSITIVE WITHOUT SAMPLES AND INSIDE IT WOULD BE SOMEWHAT FLOCCULATED, NOTHING COULD BE READ. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986382 BD BBL¿ STAPHYLOSLIDE¿ LATEX TEST KIT, 100 TESTS ANTISERA, FLUORESCENT, ALL TYPES, STAPHYLOSLIDE SPP. GTN BECTON, DICKINSON & CO. (SPARKS) 240915 C18976 00382902409151

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown