BD FACSDUET¿ SAMPLE PREP

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE "THE INSTRUMENT HAS SOME CONTAMINATION BECAUSE THE CARRIERS CAME OUT STAINED" WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: ¿ DEVICE HISTORY RECORD (DHR) REVIEW. ¿ SERVICE HISTORY REVIEW, ¿ COMPLAINT TREND, REVIEW COMPLAINT HISTORY FOR ANY SIMILAR COMPLAINT. POTENTIAL CAUSE WAS DUE TO DEFECTIVE NEEDLES WHICH WERE REPLACED TO RESOLVE THE ISSUE.

Description of Event or Problem

IT WAS REPORTED THAT CARRYOVER WAS OBSERVED DURING USE WITH THE BD FACSDUET¿ SAMPLE PREP. CONTAMINATION CHECKLIST: 1.WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN -GOT TO QUESTION #2: -CARRYOVER BETWEEN PATIENT SAMPLES THE CUSTOMER REPORTS THAT THE INSTRUMENT HAS SOME CONTAMINATION BECAUSE THE CARRIERS COME OUT STAINED.

Description of Event or Problem

IT WAS REPORTED THAT CARRYOVER WAS OBSERVED DURING USE WITH THE BD FACSDUET¿ SAMPLE PREP. CONTAMINATION CHECKLIST: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN -GOT TO QUESTION # 2: -CARRYOVER BETWEEN PATIENT SAMPLES. THE CUSTOMER REPORTS THAT THE INSTRUMENT HAS SOME CONTAMINATION BECAUSE THE CARRIERS COME OUT STAINED.

Additional Manufacturer Narrative

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