Safsite® 415068Recalls & reported problems
B. Braun Medical Inc. · RV1000NC SAFSITE VALVE W/O EXTRA CAP · Class 2
All models of Safsite (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This B. Braun Safsite valve is a one-way valve attached to intravenous lines. Its 155 reports mostly describe blood leaking from the valve after it was attached to IV cannulas, and some describe the valve working differently than expected. The reports include no deaths and no injuries. No recalls name this device. Reports dropped from 52 in the year before to 19 in the latest year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 154
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 04022495769862), received between Nov 21, 2016 and May 27, 2026 — classified as 154 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (109 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash109
- Fluid/Blood Leak22
- Device Operates Differently Than Expected20
- Reflux within Device6
- Contamination /Decontamination Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions81
- Needle Stick/Puncture22
- No Consequences Or Impact To Patient20
- Hemorrhage/Blood Loss/Bleeding18
- No Known Impact Or Consequence To Patient13
Recent adverse event reports
The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: THE ISSUE OBSERVED WAS A FAULTY VALVE, RESULTING IN BLOOD LEAKING FROM THE SITE ONCE ATTACHED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25300843 ↗MalfunctionMay 12, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: CLINICIANS REPORTED BACK FLOW OFF BLOOD LEAKING OUT OF MULTIPLE DIFFERENT SAFSITE VALVES. THE VALVES WERE CONNECTED TO A SURFLO CANNULA 20G/22G. THEY WERE NOT ATTACHED TO ANYTHING VIA THE LUER CONNECTION. SUSPECTED LOT NUMBERS WHICH WERE INVOLVED ARE: 0061968348. 0062004768. 0061966913. 0062008546. 0061998830.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148283 ↗MalfunctionMay 1, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: "I ENCOUNTERED 2 STERILE SAFSITE ONE-WAY VALVES BY BRAUN THAT WERE LEAKING PATIENT BLOOD AFTER BEING ATTACHED TO THE INTRAVENOUS CANNULAS."
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25056392 ↗MalfunctionMay 1, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: "I ENCOUNTERED 2 STERILE SAFSITE ONE-WAY VALVES BY BRAUN THAT WERE LEAKING PATIENT BLOOD AFTER BEING ATTACHED TO THE INTRAVENOUS CANNULAS."
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25056391 ↗MalfunctionApr 22, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: BLUE BUNG USED FOR PATIENTS - FOUND FAULTY, NO BLOOD PRESSURE CUFF ON THE SAME SIDE, AND NO FLUID WAS ATTACHED TO THE CANNULA, BUT AFTER SOME TIME ITS FOUND THE BLOOD WAS COMING OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955406 ↗MalfunctionApr 22, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: SAFSITE LEAKING BLOOD FROM PATIENTS AFTER BEING ATTACHED TO THE INTRAVENOUS CANNULAS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954556 ↗MalfunctionFeb 27, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: ISSUES BEING THAT THE VALVE ON THE BUNG IS CONSISTENTLY FAILING. CAUSING THE PATIENT'S BLOOD TO POUR OUT AS THERE IS NOTHING PREVENTING IT, LEADING TO A LARGE BLOOD SPILL.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24469078 ↗MalfunctionFeb 17, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: THE ITEM IS FAULTY AND DOES NOT LOCK WELL WHICH LEADS TO BLOOD SPILL. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24372473 ↗MalfunctionDec 19, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 4: REASON OF COMPLAINT: CUSTOMER STATES: "WE HAD 4 INCIDENCES OF THE SAFSITE BUNGS LEAKING - 3 OCCURRED WITH NUCLEAR MEDICINE TECHNOLOGISTS AND ONE WITH A REGISTERED NURSE." PATIENTS WERE CANNULATED, THE BUNG ATTACHED TO THE END OF THE CANNULA AND THE CANNULA TAPED DOWN. ONCE THE CAP WAS REMOVED FROM THE SAFSITE BUNG SO A FLUSH COULD BE ADMINISTERED, BLOOD STARTED TO LEAK BACK THROUGH THE ONE-WAY VALVE OF THE BUNG. BUNGS WERE SECURED TIGHTLY WE ARE ALWAYS VIGILANT WITH THIS AS WE ARE INJECTING RADIOACTIVE PHARMACEUTICALS THROUGH THESE, SO IT WAS NOT A CASE OF A LOOSE CONNECTION. IT WASN'T JUST A TRICKLE BACK THROUGH THE ONE-WAY VALVE, IT WAS A SIGNIFICANT FLOW.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23848944 ↗MalfunctionDec 19, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: REASON OF COMPLAINT: CUSTOMER STATES: WE HAD 4 INCIDENCES OF THE SAFSITE BUNGS LEAKING - 3 OCCURRED WITH NUCLEAR MEDICINE TECHNOLOGISTS AND ONE WITH A REGISTERED NURSE. PATIENTS WERE CANNULATED, THE BUNG ATTACHED TO THE END OF THE CANNULA AND THE CANNULA TAPED DOWN. ONCE THE CAP WAS REMOVED FROM THE SAFSITE BUNG SO A FLUSH COULD BE ADMINISTERED, BLOOD STARTED TO LEAK BACK THROUGH THE ONE-WAY VALVE OF THE BUNG. BUNGS WERE SECURED TIGHTLY WE ARE ALWAYS VIGILANT WITH THIS AS WE ARE INJECTING RADIOACTIVE PHARMACEUTICALS THROUGH THESE, SO IT WAS NOT A CASE OF A LOOSE CONNECTION. IT WASN'T JUST A TRICKLE BACK THROUGH THE ONE-WAY VALVE; IT WAS A SIGNIFICANT FLOW.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23848938 ↗MalfunctionDec 19, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 4: REASON OF COMPLAINT: CUSTOMER STATES: "WE HAD 4 INCIDENCES OF THE SAFSITE BUNGS LEAKING - 3 OCCURRED WITH NUCLEAR MEDICINE TECHNOLOGISTS AND ONE WITH A REGISTERED NURSE. PATIENTS WERE CANNULATED, THE BUNG ATTACHED TO THE END OF THE CANNULA AND THE CANNULA TAPED DOWN. ONCE THE CAP WAS REMOVED FROM THE SAFSITE BUNG SO A FLUSH COULD BE ADMINISTERED, BLOOD STARTED TO LEAK BACK THROUGH THE ONE-WAY VALVE OF THE BUNG. BUNGS WERE SECURED TIGHTLY WE ARE ALWAYS VIGILANT WITH THIS AS WE ARE INJECTING RADIOACTIVE PHARMACEUTICALS THROUGH THESE, SO IT WAS NOT A CASE OF A LOOSE CONNECTION. IT WASN'T JUST A TRICKLE BACK THROUGH THE ONE-WAY VALVE; IT WAS A SIGNIFICANT FLOW.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23848936 ↗MalfunctionDec 19, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: REASON OF COMPLAINT: CUSTOMER STATES: "WE HAD 4 INCIDENCES OF THE SAFESITE BUNGS LEAKING - 3 OCCURRED WITH NUCLEAR MEDICINE TECHNOLOGISTS AND ONE WITH A REGISTERED NURSE. PATIENTS WERE CANNULATED, THE BUNG ATTACHED TO THE END OF THE CANNULA AND THE CANNULA TAPED DOWN. ONCE THE CAP WAS REMOVED FROM THE SAFESITE BUNG SO A FLUSH COULD BE ADMINISTERED, BLOOD STARTED TO LEAK BACK THROUGH THE ONE-WAY VALVE OF THE BUNG. BUNGS WERE SECURED TIGHTLY WE ARE ALWAYS VIGILANT WITH THIS AS WE ARE INJECTING RADIOACTIVE PHARMACEUTICALS THROUGH THESE, SO IT WAS NOT A CASE OF A LOOSE CONNECTION. IT WASN'T JUST A TRICKLE BACK THROUGH THE ONE-WAY VALVE, IT WAS A SIGNIFICANT FLOW.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23848935 ↗MalfunctionNov 15, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: SAFESITE VALVE LEAKING AFTER DISCONNECTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563849 ↗MalfunctionNov 14, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: DURING THERAPY BLOOD WAS OBSERVED LEAKING OUT OF A SAFSITE VALVE ON DISCONNECTION OF A LUER DEVICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23554990 ↗MalfunctionNov 14, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: DURING THERAPY BLOOD WAS OBSERVED LEAKING OUT OF A SAFSITE VALVE ON DISCONNECTION OF A LUER DEVICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23554989 ↗MalfunctionNov 14, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 3: DURING THERAPY BLOOD WAS OBSERVED LEAKING OUT OF A SAFSITE VALVE ON DISCONNECTION OF A LUER DEVICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23554988 ↗MalfunctionNov 12, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: END USER IS HAVING FREQUENT FAILURES/LEAKING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23535294 ↗MalfunctionNov 5, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DURING THERAPY BLOOD BACKFLOW WAS OBSERVED. THE BACKFLOW TRAVELED UP THE IV LINE AND OUT THE EXIT SITE. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23479600 ↗MalfunctionOct 31, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 4: DURING THERAPY THE SAFSITE ALLOWED BLOOD TO REFLUX FROM THE CANNULA OUT OF THE VALVE AFTER INSERTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435988 ↗MalfunctionOct 31, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 3: DURING THERAPY THE SAFSITE ALLOWED BLOOD TO REFLUX FROM THE CANNULA OUT OF THE VALVE AFTER INSERTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435987 ↗MalfunctionOct 31, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: DURING THERAPY THE SAFSITE ALLOWED BLOOD TO REFLUX FROM THE CANNULA OUT OF THE VALVE AFTER INSERTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435985 ↗MalfunctionOct 31, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: DURING THERAPY THE SAFSITE ALLOWED BLOOD TO REFLUX FROM THE CANNULA OUT OF THE VALVE AFTER INSERTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435984 ↗MalfunctionOct 31, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: BLOOD OBSERVED TO BE LEAKING OUT OF 3X SEPARATE SAFSITE VALVES ALL ON THE SAME DAY. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435612 ↗MalfunctionOct 31, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: BLOOD OBSERVED TO BE LEAKING OUT OF 3X SEPARATE SAFSITE VALVES ALL ON THE SAME DAY. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435611 ↗MalfunctionOct 31, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 3: BLOOD OBSERVED TO BE LEAKING OUT OF 3X SEPARATE SAFSITE VALVES ALL ON THE SAME DAY. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435610 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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