BD BBL¿ STAPHYLOSLIDE¿ LATEX TEST KIT, 100 TESTS

Additional Manufacturer Narrative

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

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

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

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. "