BD FACSLYRIC¿
Received Oct 3, 2023 · Event occurred Sep 19, 2023
Report 2916837-2023-00189 · MDR key 17865279
Device
Generic name
Flow Cytometric Reagents And Access
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
659180
Lot number
NA
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CARRY OVER FROM TUBE TO TUBE. DID ANY LIQUID LEAKAGE OR SPLASH OR SPRAY COME INTO CONTACT WITH EYES OR MOUTH OR ANY MUCOUS MEMBRANE OR NON-INTACT(BROKEN) SKIN? NO WERE SAMPLES CONTAMINATED? YES ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? NO CALLER REPORTS THIS STARTED A COUPLE OF DAYS AGO CARRY OVER FROM TUBE TO TUBE.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED: G.1. (B)(6). INVESTIGATION SUMMARY: BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICE MAX ACTIVITY, THE REPORTED ISSUE 'CARRY OVER FROM TUBE TO TUBE' WAS CONFIRMED AND THE POTENTIAL CAUSE OF THE CUSTOMER EXPERIENCING CARRYOVER ISSUES ON THE FACSLYRIC WAS DETERMINED TO BE CLOGGED FLUIDICS LINE. FSE PERFORMED SYSTEM CHECKS AND THEN CLEANED THE INSTRUMENT WITH FACSCLEAN. AFTERWARDS, THE INSTRUMENT IS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
Additional Manufacturer Narrative
D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. 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 CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CARRY OVER FROM TUBE TO TUBE. DID ANY LIQUID LEAKAGE OR SPLASH OR SPRAY COME INTO CONTACT WITH EYES OR MOUTH OR ANY MUCOUS MEMBRANE OR NON-INTACT(BROKEN) SKIN? NO. WERE SAMPLES CONTAMINATED? YES. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? NO. CALLER REPORTS THIS STARTED A COUPLE OF DAYS AGO. CARRY OVER FROM TUBE TO TUBE.