SafeDAY™ 352899Recalls & reported problems
B. Braun Medical Inc. · 15 DROP UNIVERSAL IV ADMIN SET W/3 BLUE · Class 2
All models of SafeDAY (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046964181931), received between Nov 23, 2016 and Sep 3, 2020 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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 Expected3
- Contamination /Decontamination Problem2
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE IV TUBING DISCONNECTED AND ALLOWED BLOOD TO BACK UP INTO THE TUBING & WAS RUNNING ON THE FLOOR. POSSIBLE LOT NUMBER OF THE TUBING INVOLVED 0061714675. PLEASE NOTE THAT OUR SYSTEM INDICATES THAT THIS LOT DOES NOT EXIST FOR REPORTED MATERIAL NUMBER (B)(4). NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10487845 ↗MalfunctionApr 8, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT BLACK PARTICLES WERE IN THE DRIP CHAMBER. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9935641 ↗MalfunctionAug 31, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THAT BROWN PARTICLES WERE FOUND IN THE DRIP CHAMBER. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7837115 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 3. BLOOD BACKING UP INTO THE TUBING. THE BLOOD WAS LEAKING FROM THE MIDDLE Y-SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124494 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 1: BLOOD BACKING UP INTO THE TUBING. THE BLOOD WAS LEAKING FROM THE MIDDLE Y-SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124485 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 2: BLOOD BACKING UP INTO THE TUBING. THE BLOOD WAS LEAKING FROM THE MIDDLE Y-SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124474 ↗
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
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- 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.
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