FACSVia 662386Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382906623867), received between Dec 28, 2020 and Sep 8, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING THE BD FACSVIA¿ SYSTEM, THERE WAS WASTE LEAKAGE WITHOUT BLEACH NOT CONTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THAT THERE WAS LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN INSTRUMENT. THE RED LINE IS POPPING OFF NEAR THE WASTE PUMP. FLUIDIC DID LEAK OUT OF INSTRUMENT. CUSTOMER PUT LINE BACK ON AND IT POPPED OFF AGAIN. PUMP SEEMS TO STRUGGLE BEFORE LINE POPS OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15384825 ↗
• MalfunctionJul 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE BD FACSVIA¿ SYSTEM HAD WASTE LEAKAGE WITHOUT BLEACH NOT CONTAINED (OUTSIDE INSTRUMENT), AND LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN INSTRUMENT. INTERNAL NOTES: LEAK (IF YES EXPLAIN)? YES. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. 3. WHAT WAS THE FLUID THAT LEAKED? SHEATH FLUIID/WASTE. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? YES, IT WAS ON THE COUNTER, BUT NOT TOUCH TO MY KNOWLEDGE. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO IT WAS REPORTED BY THE CUSTOMER THAT THE BD FACSVIA HAD LEAKING FLUID ON THE COUNTERTOP. CUSTOMER PROBLEM: CUSTOMER CALLED BECAUSE THERE IS A LEAK FROM THE VIA STEPS TAKEN WITH CUSTOMER/ TROUBLESHOOTING: SPOKE WITH CUSTOMERAND HER LEAK IS COMING FROM THE BODY OF THE VIA. SHE CAN NOT TELL WHERE AS THE SEEM IS WET. SHE HAS SPOKEN WITH HER FSE AND HHE ASKED HER TO PLACE A SERVICE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946859 ↗
• MalfunctionFeb 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD FACSVIA¿ SYSTEM WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE WASTE BOTTLE. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THE CUSTOMER REPORTS THAT THE TAN QUICK CONNECT ON THE WASTE BOTTLE CAP IS BROKEN, NOT ALLOWING FLUID TO GO INTO THE TANK AND CAUSING IT TO POOL UP ON THE CAP. THE INSTRUMENT IS DOWN AND OUT OF SERVICE. THEY HAVE SAMPLES THAT WILL KEEP OVER THE WEEKEND, BUT MUST BE RUN ON MONDAY, SO AS A COURTESY I AM GOING TO SEND HER A NEW WASTE BOTTLE (P/N 659605) SO THAT THEY WILL NOT LOSE THEIR SAMPLES. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. RESOLUTION ACHIEVED? YES. FOLLOW UP REQUIRED? YES. WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED/SPILLED? WASTE. WHAT IS THE SOURCE OF LEAK/SPILL (WASTE OR NON-WASTE LINE)? WASTE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PH

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11342899 ↗
• MalfunctionDec 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING BD FACSVIA¿ SYSTEM THE WASTE LINE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO IMPACT TO USER OR PATIENT. IT WAS REPORTED THAT THE WASTE LINE IS LEAKING. THERE WAS NO SPRAY OF FLUID UNDER PRESSURE AND NO ONE WAS INJURED. IS INSTRUMENT ASSURITY LINC ENABLED? (Y/N) NO CUSTOMER PROBLEM: WASTE LINE IS LEAKING STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CTS TO TROUBLESHOOT NEXT STEPS (IF NECESSARY): FORWARD CASE TO CTS FOR TROUBLESHOOTING ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO WAS THERE ANY INJURY OR POTENTIAL INJURY? NO LEAK (IF YES EXPLAIN)? YES 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES 3. WHAT WAS THE FLUID THAT LEAKED? SHEATH 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? UNKNOWN 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11077216 ↗