SafeDAY™ 352900Recalls & reported problems
B. Braun Medical Inc. · 15DR UNIV IV ADMIN SET W/1 BLU ULTRASITE · Class 2
All models of SafeDAY (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04046964181955), received between Nov 23, 2016 and Jan 16, 2020 — classified as 14 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
- Contamination /Decontamination Problem1
- Infusion or Flow Problem1
Patient problems
- No Consequences Or Impact To Patient12
- No Known Impact Or Consequence To Patient2
- Blood Loss1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: PER END USER, THE Y-SITE HAS BLACK "INK TYPE" SUBSTANCE ON IT. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9595930 ↗MalfunctionMay 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE PRODUCT WAS FOUND TO BE LEAKING AT THE INJECTION SITE, CAUSING A CHEMOTHERAPY DRUG TO LEAK ONTO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8570317 ↗MalfunctionJun 21, 2018Infusion or Flow Problem; Infusion or Flow Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS ISSUE OF BUBBLE ACCUMULATION IN THE TUBING WHEN INFUSING GARMUNEX C. ISSUE IS NOTED WITHIN THE FIRST 1/2 HOUR OF INFUSION. PUMP ALARMS AIR IN LINE AND IT IS A TRUE ALARM, AS WELL AS OTHER AIR NOTED IN TUBING. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7626758 ↗MalfunctionJun 1, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING A DIALYSIS TREATMENT, THE NURSE NOTICED THAT THE IV SET HAD A HOLE IN THE TUBING. THE NURSE EXPLAINED THAT WHEN SHE WAS RUNNING THE INFUSION, A FEW MINUTES AFTER, THE PATIENT'S ANTIBIOTIC AND BLOOD STARTED LEAKING OUT OF A HOLE IN THE IV TUBING. THE PATIENT HAD LOST APPROXIMATELY 200CC OF BLOOD AND ANTIBIOTIC MIXTURE BY THE TIME THE NURSE RECOGNIZED THE LEAK. THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR LABS AND MONITORING OF VITAL SIGNS. PATIENT HAD NO ILL EFFECTS OF THE BLOOD LOSS AND DID NOT REQUIRE ANY FURTHER MEDICAL INTERVENTION.
Patient problems: Blood Loss; No Consequences Or Impact To Patient
MAUDE report 7560357 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 5. NO PATIENT INJURY REPORTED. EVENT DESCRIPTION: CLINICIAN PRIMES BAG WITH NORMAL SALINE, CLAMPS THE LINE BY CLOSING THE ROLLER CLAMP BUT FLUIDS STILL LEAK FROM THE DISTAL CONNECTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6125517 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 4. NO PATIENT INJURY REPORTED. EVENT DESCRIPTION: CLINICIAN PRIMES BAG WITH NORMAL SALINE, CALMPS THE LINE BY CLOSING THE ROLLER CLAMP BUT FLUIDS STILL LEAK FROM THE DISTAL CONNECTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6125504 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 10. NO PATIENT INJURY REPORTED. EVENT DESCRIPTION: CLINICIAN PRIMES BAG WITH NORMAL SALINE, CLAMPS THE LINE BY CLOSING THE ROLLER CLAMP BUT FLUIDS STILL LEAK FROM THE DISTAL CONNECTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6125283 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 6. NO PATIENT INJURY REPORTED. EVENT DESCRIPTION: CLINICIAN PRIMES BAG WITH NORMAL SALINE, CLAMPS THE LINE BY CLOSING THE ROLLER CLAMP BUT FLUIDS STILL LEAK FROM THE DISTAL CONNECTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6125274 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 9. NO PATIENT INJURY REPORTED. EVENT DESCRIPTION: CLINICIAN PRIMES BAG WITH NORMAL SALINE, CALMPS THE LINE BY CLOSING THE ROLLER CLAMP BUT FLUIDS STILL LEAK FROM THE DISTAL CONNECTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6125260 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 7. NO PATIENT INJURY REPORTED. EVENT DESCRIPTION: CLINICIAN PRIMES BAG WITH NORMAL SALINE, CLAMPS THE LINE BY CLOSING THE ROLLER CLAMP BUT FLUIDS STILL LEAK FROM THE DISTAL CONNECTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6125257 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 3 NO PATIENT INJURY REPORTED. EVENT DESCRIPTION: CLINICIAN PRIMES BAG WITH NORMAL SALINE, CALMPS THE LINE BY CLOSING THE ROLLER CLAMP BUT FLUIDS STILL LEAK FROM THE DISTAL CONNECTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6125251 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 2: NO PATIENT INJURY REPORTED. EVENT DESCRIPTION: CLINICIAN PRIMES BAG WITH NORMAL SALINE, CLAMPS THE LINE BY CLOSING THE ROLLER CLAMP BUT FLUIDS STILL LEAK FROM THE DISTAL CONNECTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6125233 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 1. NO PATIENT INJURY REPORTED. EVENT DESCRIPTION: CLINICIAN PRIMES BAG WITH NORMAL SALINE, CLAMPS THE LINE BY CLOSING THE ROLLER CLAMP BUT FLUIDS STILL LEAK FROM THE DISTAL CONNECTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6125226 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 8. NO PATIENT INJURY REPORTED. EVENT DESCRIPTION: CLINICIAN PRIMES BAG WITH NORMAL SALINE, CLAMPS THE LINE BY CLOSING THE ROLLER CLAMP BUT FLUIDS STILL LEAK FROM THE DISTAL CONNECTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6125217 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page