BD FACSLYRIC¿ CEIVD

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ CEIVD CARRYOVER OCCURRED INVOLVING PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: SMALL ISSUE WITH RESIDUE ON THE NEEDLE AFTER TESTING. CONTAMINATION 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS ARE REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION # 2. UNKNOWN, MAYBE CARRYOVER BETWEEN PATIENT SAMPLES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. THE SIT FLUSH WAS ONLY PARTIALLY EFFECTIVE; AS A RESULT, THE CLEANING OF THE SIT MAY HAVE BEEN INADEQUATE, WITH A POTENTIAL RISK OF CARRYOVER BETWEEN SAMPLES.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING CONTAMINATION - CARRY OVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING RESIDUE ON THE NEEDLE WAS LINKED TO THE FLUIDIC SYSTEM. THE ISSUE WAS RESOLVED AFTER THE PART WAS REPLACED. THE REPLACED PART WAS NOT RETURNABLE; THEREFORE, IT WAS DISCARDED. NO FURTHER PROBLEMS WERE NOTED, AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ CEIVD CARRYOVER OCCURRED INVOLVING PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: SMALL ISSUE WITH RESIDUE ON THE NEEDLE AFTER TESTING. CONTAMINATION: WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS ARE REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. UNKNOWN, MAYBE CARRYOVER BETWEEN PATIENT SAMPLES. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. THE SIT FLUSH WAS ONLY PARTIALLY EFFECTIVE; AS A RESULT, THE CLEANING OF THE SIT MAY HAVE BEEN INADEQUATE, WITH A POTENTIAL RISK OF CARRYOVER BETWEEN SAMPLES.