SafeDAY™ 352894Recalls & reported problems
B. Braun Medical Inc. · UNIVERSAL IV SET W/ TWO BLUE ULTRASITES · Class 2
All models of SafeDAY (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This B. Braun SafeDAY universal IV set is a two-port intravenous administration set with blue ultrasound sites. The 34 reports mostly describe leaking — cracked or snapped tubing and leaking chambers during chemotherapy — plus air-in-line alarms on pumps, vents popping off, and one report of rust-colored dirt inside the chamber. No deaths or injuries were reported, and no recalls name this device.
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
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04046964181894), received between Jul 7, 2017 and Dec 27, 2021 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (28 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
- Fluid/Blood Leak28
- Contamination /Decontamination Problem3
- Adverse Event Without Identified Device or Use Problem1
- Improper Flow or Infusion1
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient15
- No Consequences Or Impact To Patient14
- No Clinical Signs, Symptoms or Conditions7
- Blood Loss1
- Chills1
- Malaise1
- Nausea1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET HAS A DIRTY CHAMBER. THERE IS BROWN RUST COLORED DIRT INSIDE OF THE CHAMBER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13090734 ↗MalfunctionMar 19, 2021Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY THE USER FACILITY: THE NURSE IS EXPERIENCING AIR IN LINE ALARMS ON THE VISTA PUMP WHEN ADMINISTERING IVIG IN GLASS BOTTLE VIA TUBING 352894. THIS DOES NOT HAPPEN WITH FLUIDS IN SOFT IV CONTAINERS. THE SOLUTION IS NOT COLD WHEN ADMINISTERED. THE TUBING IS VENTED. SHE SOMETIMES SEES SMALL BUBBLES. SHE GETS ALARMS WHEN THIS OCCURS AND SHE RESOLVES BY OPENING THE DOOR AND CLEARING THE TUBING OF THE BUBBLES. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11526987 ↗MalfunctionAug 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE PRODUCT CRACKED AND LEAKED DURING CHEMO USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10397496 ↗MalfunctionAug 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: IT WAS REPORTED THAT THE PRODUCT CRACKED AND LEAKED DURING CHEMO USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10397481 ↗MalfunctionAug 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT THE PRODUCT CRACKED AND LEAKED DURING CHEMO USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10397480 ↗MalfunctionAug 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE PRODUCT CRACKED AND LEAKED DURING CHEMO USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10397390 ↗MalfunctionJan 9, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: END USER STATED THAT DURING CHEMOTHERAPHY OF CISPLATIN, THE TUBING SNAPPED AND LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9569566 ↗MalfunctionMar 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: END CUSTOMER STATED "THE VENTS ARE POPPING OFF OF THE IV SETS". THIS HAS BEEN HAPPENING FOR ABOUT 6 MONTHS WITH RANDOM LOT NUMBERS. THE FACILITY USES APPROXIMATELY 100 SETS PER DAY AND THEY AVERAGE ABOUT 6-10 IV SETS PER WEEK WITH VENT ISSUES. THE SETS ARE OCCURRING WITH BOTH REGULAR IV MAINTENANCE SOLUTIONS AS WELL AS WITH CHEMOTHERAPY AGENTS (NO SPECIFIC CHEMOTHERAPY AGENTS). NURSES ARE HAVING CHEMOTHERAPY EXPOSURE. THE NURSES ARE WEARING APPROPRIATE PPES AND ARE CLEANING UP THE CHEMOTHERAPY SPILLS ACCORDING TO FACILITY PROTOCOL. NO INJURIES HAVE OCCURRED AS A RESULT OF THE EXPOSURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8382327 ↗MalfunctionMar 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: END CUSTOMER STATED "THE VENTS ARE POPPING OFF OF THE IV SETS". THIS HAS BEEN HAPPENING FOR ABOUT 6 MONTHS WITH RANDOM LOT NUMBERS. THE FACILITY USES APPROXIMATELY 100 SETS PER DAY AND THEY AVERAGE ABOUT 6-10 IV SETS PER WEEK WITH VENT ISSUES. THE SETS ARE OCCURRING WITH BOTH REGULAR IV MAINTENANCE SOLUTIONS AS WELL AS WITH CHEMOTHERAPY AGENTS (NO SPECIFIC CHEMOTHERAPY AGENTS). NURSES ARE HAVING CHEMOTHERAPY EXPOSURE. THE NURSES ARE WEARING APPROPRIATE PPES AND ARE CLEANING UP THE CHEMOTHERAPY SPILLS ACCORDING TO FACILITY PROTOCOL. NO INJURIES HAVE OCCURRED AS A RESULT OF THE EXPOSURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8382325 ↗MalfunctionMar 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 9: END CUSTOMER STATED "THE VENTS ARE POPPING OFF OF THE IV SETS". THIS HAS BEEN HAPPENING FOR ABOUT 6 MONTHS WITH RANDOM LOT NUMBERS. THE FACILITY USES APPROXIMATELY 100 SETS PER DAY AND THEY AVERAGE ABOUT 6-10 IV SETS PER WEEK WITH VENT ISSUES. THE SETS ARE OCCURRING WITH BOTH REGULAR IV MAINTENANCE SOLUTIONS AS WELL AS WITH CHEMOTHERAPY AGENTS (NO SPECIFIC CHEMOTHERAPY AGENTS). NURSES ARE HAVING CHEMOTHERAPY EXPOSURE. THE NURSES ARE WEARING APPROPRIATE PPES AND ARE CLEANING UP THE CHEMOTHERAPY SPILLS ACCORDING TO FACILITY PROTOCOL. NO INJURIES HAVE OCCURRED AS A RESULT OF THE EXPOSURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8382322 ↗MalfunctionMar 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 8: END CUSTOMER STATED "THE VENTS ARE POPPING OFF OF THE IV SETS". THIS HAS BEEN HAPPENING FOR ABOUT 6 MONTHS WITH RANDOM LOT NUMBERS. THE FACILITY USES APPROXIMATELY 100 SETS PER DAY AND THEY AVERAGE ABOUT 6-10 IV SETS PER WEEK WITH VENT ISSUES. THE SETS ARE OCCURRING WITH BOTH REGULAR IV MAINTENANCE SOLUTIONS AS WELL AS WITH CHEMOTHERAPY AGENTS (NO SPECIFIC CHEMOTHERAPY AGENTS). NURSES ARE HAVING CHEMOTHERAPY EXPOSURE. THE NURSES ARE WEARING APPROPRIATE PPES AND ARE CLEANING UP THE CHEMOTHERAPY SPILLS ACCORDING TO FACILITY PROTOCOL. NO INJURIES HAVE OCCURRED AS A RESULT OF THE EXPOSURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8382321 ↗MalfunctionMar 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: END CUSTOMER STATED "THE VENTS ARE POPPING OFF OF THE IV SETS". THIS HAS BEEN HAPPENING FOR ABOUT 6 MONTHS WITH RANDOM LOT NUMBERS. THE FACILITY USES APPROXIMATELY 100 SETS PER DAY AND THEY AVERAGE ABOUT 6-10 IV SETS PER WEEK WITH VENT ISSUES. THE SETS ARE OCCURRING WITH BOTH REGULAR IV MAINTENANCE SOLUTIONS AS WELL AS WITH CHEMOTHERAPY AGENTS (NO SPECIFIC CHEMOTHERAPY AGENTS). NURSES ARE HAVING CHEMOTHERAPY EXPOSURE. THE NURSES ARE WEARING APPROPRIATE PPES AND ARE CLEANING UP THE CHEMOTHERAPY SPILLS ACCORDING TO FACILITY PROTOCOL. NO INJURIES HAVE OCCURRED AS A RESULT OF THE EXPOSURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8382318 ↗MalfunctionMar 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 6: END CUSTOMER STATED "THE VENTS ARE POPPING OFF OF THE IV SETS". THIS HAS BEEN HAPPENING FOR ABOUT 6 MONTHS WITH RANDOM LOT NUMBERS. THE FACILITY USES APPROXIMATELY 100 SETS PER DAY AND THEY AVERAGE ABOUT 6-10 IV SETS PER WEEK WITH VENT ISSUES. THE SETS ARE OCCURRING WITH BOTH REGULAR IV MAINTENANCE SOLUTIONS AS WELL AS WITH CHEMOTHERAPY AGENTS (NO SPECIFIC CHEMOTHERAPY AGENTS). NURSES ARE HAVING CHEMOTHERAPY EXPOSURE. THE NURSES ARE WEARING APPROPRIATE PPES AND ARE CLEANING UP THE CHEMOTHERAPY SPILLS ACCORDING TO FACILITY PROTOCOL. NO INJURIES HAVE OCCURRED AS A RESULT OF THE EXPOSURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8382317 ↗MalfunctionMar 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 5: END CUSTOMER STATED "THE VENTS ARE POPPING OFF OF THE IV SETS". THIS HAS BEEN HAPPENING FOR ABOUT 6 MONTHS WITH RANDOM LOT NUMBERS. THE FACILITY USES APPROXIMATELY 100 SETS PER DAY AND THEY AVERAGE ABOUT 6-10 IV SETS PER WEEK WITH VENT ISSUES. THE SETS ARE OCCURRING WITH BOTH REGULAR IV MAINTENANCE SOLUTIONS AS WELL AS WITH CHEMOTHERAPY AGENTS (NO SPECIFIC CHEMOTHERAPY AGENTS). NURSES ARE HAVING CHEMOTHERAPY EXPOSURE. THE NURSES ARE WEARING APPROPRIATE PPES AND ARE CLEANING UP THE CHEMOTHERAPY SPILLS ACCORDING TO FACILITY PROTOCOL. NO INJURIES HAVE OCCURRED AS A RESULT OF THE EXPOSURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8382316 ↗MalfunctionMar 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 7: END CUSTOMER STATED "THE VENTS ARE POPPING OFF OF THE IV SETS". THIS HAS BEEN HAPPENING FOR ABOUT 6 MONTHS WITH RANDOM LOT NUMBERS. THE FACILITY USES APPROXIMATELY 100 SETS PER DAY AND THEY AVERAGE ABOUT 6-10 IV SETS PER WEEK WITH VENT ISSUES. THE SETS ARE OCCURRING WITH BOTH REGULAR IV MAINTENANCE SOLUTIONS AS WELL AS WITH CHEMOTHERAPY AGENTS (NO SPECIFIC CHEMOTHERAPY AGENTS). NURSES ARE HAVING CHEMOTHERAPY EXPOSURE. THE NURSES ARE WEARING APPROPRIATE PPES AND ARE CLEANING UP THE CHEMOTHERAPY SPILLS ACCORDING TO FACILITY PROTOCOL. NO INJURIES HAVE OCCURRED AS A RESULT OF THE EXPOSURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8382313 ↗MalfunctionMar 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 10: END CUSTOMER STATED "THE VENTS ARE POPPING OFF OF THE IV SETS". THIS HAS BEEN HAPPENING FOR ABOUT 6 MONTHS WITH RANDOM LOT NUMBERS. THE FACILITY USES APPROXIMATELY 100 SETS PER DAY AND THEY AVERAGE ABOUT 6-10 IV SETS PER WEEK WITH VENT ISSUES. THE SETS ARE OCCURRING WITH BOTH REGULAR IV MAINTENANCE SOLUTIONS AS WELL AS WITH CHEMOTHERAPY AGENTS (NO SPECIFIC CHEMOTHERAPY AGENTS). NURSES ARE HAVING CHEMOTHERAPY EXPOSURE. THE NURSES ARE WEARING APPROPRIATE PPES AND ARE CLEANING UP THE CHEMOTHERAPY SPILLS ACCORDING TO FACILITY PROTOCOL. NO INJURIES HAVE OCCURRED AS A RESULT OF THE EXPOSURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8382310 ↗MalfunctionMar 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: END CUSTOMER STATED "THE VENTS ARE POPPING OFF OF THE IV SETS". THIS HAS BEEN HAPPENING FOR ABOUT 6 MONTHS WITH RANDOM LOT NUMBERS. THE FACILITY USES APPROXIMATELY 100 SETS PER DAY AND THEY AVERAGE ABOUT 6-10 IV SETS PER WEEK WITH VENT ISSUES. THE SETS ARE OCCURRING WITH BOTH REGULAR IV MAINTENANCE SOLUTIONS AS WELL AS WITH CHEMOTHERAPY AGENTS (NO SPECIFIC CHEMOTHERAPY AGENTS). NURSES ARE HAVING CHEMOTHERAPY EXPOSURE. THE NURSES ARE WEARING APPROPRIATE PPES AND ARE CLEANING UP THE CHEMOTHERAPY SPILLS ACCORDING TO FACILITY PROTOCOL. NO INJURIES HAVE OCCURRED AS A RESULT OF THE EXPOSURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8382306 ↗MalfunctionOct 4, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: UPON PRIMING THE IV TUBING IT WAS NOTICED THAT THE SET WAS LEAKING SIGNIFICANTLY FROM WHERE THE TUBING CONNECTS AT THE DISTAL Y-SITE. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7933587 ↗MalfunctionOct 4, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT UPON ADMINISTERING VERSED AND FENTANYL, DURING A WISDOM TOOTH EXTRACTION, BLOOD WAS COMING BACK UP THE IV TUBING TO THE DISTAL Y-SITE, AND BLOOD LEAKED ONTO THE FLOOR. THE PROCEDURE WAS ACTUALLY COMPLETED WHEN THE BLOOD LEAK WAS NOTICED. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECTS AND DID NOT REQUIRE ANY ADDITIONAL INTERVENTION.
Patient problems: Blood Loss
MAUDE report 7933584 ↗MalfunctionAug 10, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: AS THE NURSE WAS ADMINISTRATING THE ADRIAMYCIN IV PUSH, THE LL ADAPTER STRIPPED OFF THE Y-SITE OF THE SAFEDAY SET, CAUSING THE ADRIAMYCIN TO LEAK. A CHEMO KIT WAS USED TO CLEAN UP THE SPILL. NO INJURIES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7774086 ↗MalfunctionJul 23, 2018Leak/Splash; Leak/Splash
AS REPORTED BY USER FACILITY: FILTER FELL OUT OF THE VENT ON THE DRIP CHAMBER AND FLUID LEAKED OUT OF THE HOLE. PATIENT RECEIVED FULL TREATMENT. NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 7710347 ↗MalfunctionJul 17, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT A BLACK DOT WAS SEEN INSIDE THE DRIP CHAMBER. ONE SET HAS NORMAL SALINE IN IT AND THE OTHER IS DRY. NO INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7693748 ↗MalfunctionJul 17, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT A BLACK DOT WAS SEEN INSIDE THE DRIP CHAMBER. ONE SET HAS NORMAL SALINE IN IT AND THE OTHER IS DRY. NO INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7693744 ↗MalfunctionMay 29, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT SEVERAL IV SETS LEAKED DURING CHEMOTHERAPY. LIMITED INFORMATION PROVIDED. NO INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7548886 ↗MalfunctionMay 17, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE IV SET LEAKED CHEMOTHERAPY AT THE UPPER Y-SITE JUNCTION. NO INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7523400 ↗
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