FACSCAN¿ FLOW CYTOMETER
Received Jul 15, 2022 · Event occurred Jun 23, 2022
Report 2916837-2022-00186 · MDR key 15033171
Device
Generic name
Automated Cell Counter
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
00-05000-10
Lot number
NA
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING FACSCAN¿ FLOW CYTOMETER LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLEASE CONFIRM THE SAFETY CHECK BELOW. WAS THE LEAK FLUID OR AIR ? FLUID, WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT ? NO, WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO, WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD , DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE, WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? NO, WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.
Additional Manufacturer Narrative
INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING FACSCAN¿ FLOW CYTOMETER LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLEASE CONFIRM THE SAFETY CHECK BELOW. 1. WAS THE LEAK FLUID OR AIR FLUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT NO. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. 6. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? NO. 7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO".
Additional Manufacturer Narrative
THE MDR WAS CHANGED FROM REPORTABLE FOR LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT TO LEAKAGE OF NON BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT. THIS SUPPLEMENTAL WAS CREATED TO CANCEL MFR #2916837-2022-00186.THIS MDR SHOULD BE CONSIDERED CANCELED.