SafeDAY™ 415108Recalls & reported problems
B. Braun Medical Inc. · SAFEDAY(TM) VALVE · Class 2
All models of SafeDAY (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04046964296215), received between Nov 22, 2016 and Nov 4, 2019 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (10 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
Device problems
- Device Operates Differently Than Expected10
- Fluid/Blood Leak2
Patient problems
- No Consequences Or Impact To Patient10
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: END USER REPORTS, THAT THE CONNECTIONS FROM THE VALVE TO THE J-LOOP WAS NOT ABLE TO BE SECURED CAUSING LEAKAGE. THE END USER ATTEMPTED SEVERAL TIMES TO ATTACH THE VALVE BY TAKING IT OFF AND ATTEMPTING TO RETHREAD IT, HOWEVER THE CONNECTIONS WAS STILL POOR AND LEAKING CONTINUED DURING FLUSHING WITH NORMAL SALINE. NORMAL SALINE AND BLOOD LEAKED FROM THE PATIENT WHEN ATTEMPTING TO PULL BACK ON THE VALVE. A NEW VALVE WAS PLACED WITH NO COMPLICATIONS. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9271295 ↗MalfunctionMay 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: BLOOD LEAKAGE IS OCCURRING WHILE ATTACHING THE SAFEDAY VALVE TO THE INTROCAN SAFETY 3. A SMALL AMOUNT OF BLOOD LEAKS DURING CONNECTING, AND OCCURS AFTER THE DRESSING IS APPLIED OR AT THE TIME OF THE CATHETER REMOVAL. THIS HAS BEEN OCCURRING INTERMITTENTLY, WITH ONE CLINICIAN REPORTING THE ISSUE SEVERAL TIMES. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8603022 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 9. LEAKING BOTH BLOOD AND SALINE BETWEEN THE INTROCAN AND LUER LOCK OF THE SAFEDAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120443 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 10: LEAKING BOTH BLOOD AND SALINE BETWEEN THE INTROCAN AND LUER LOCK OF THE SAFEDAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120429 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 7. LEAKING BOTH BLOOD AND SALINE BETWEEN THE INTROCAN AND LUER LOCK OF THE SAFEDAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120394 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY:EVENT 8:LEAKING BOTH BLOOD AND SALINE BETWEEN THE INTROCAN AND LUER LOCK OF THE SAFEDAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120392 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 6. LEAKING BOTH BLOOD AND SALINE BETWEEN THE INTROCAN AND LUER LOCK OF THE SAFEDAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120383 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 5. LEAKING BOTH BLOOD AND SALINE BETWEEN THE INTROCAN AND LUER LOCK OF THE SAFEDAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120378 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 2: LEAKING BOTH BLOOD AND SALINE BETWEEN THE INTROCAN AND LUER LOCK OF THE SAFEDAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120368 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 4. LEAKING BOTH BLOOD AND SALINE BETWEEN THE INTROCAN AND LUER LOCK OF THE SAFEDAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120363 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 3: LEAKING BOTH BLOOD AND SALINE BETWEEN THE INTROCAN AND LUER LOCK OF THE SAFEDAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120360 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 1: LEAKING BOTH BLOOD AND SALINE BETWEEN THE INTROCAN AND LUER LOCK OF THE SAFEDAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120354 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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