SafsiteRecalls & reported problems across all models

We found 7 models of Safsite by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 190 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and May 27, 2026 — classified as 190 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (112 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Safsite problems

Safsite models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Safsite® 415068

  Set, administration, intravascular
  154 reports
• Safsite® 472060

  Set, administration, intravascular
  11 reports
• Safsite® 471987

  Set, administration, intravascular
  9 reports
• Safsite® 415067

  Set, administration, intravascular
  7 reports
• Safsite® 473063

  Set, administration, intravascular
  7 reports
• Safsite® 415069

  Set, administration, intravascular
  1 report
• Safsite® 352072

  Set, administration, intravascular
  1 report

Recent Safsite adverse event reports

The 15 most recent reports across all models, 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 ↗

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