IV Administration Set 352640Recalls & reported problems
B. Braun Medical Inc. · IV ADMIN SET 15 DROP W/3 SAFEDAY · Class 2
All models of IV Administration Set (153)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046955594696), received between Nov 15, 2021 and Feb 11, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Oct 29, 2025Open, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0670-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash2
- Contamination /Decontamination Problem1
- Free or Unrestricted Flow1
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Free or Unrestricted Flow
AS REPORTED BY THE USER FACILITY: TUBING DOES NOT COMPLETELY CLAMP OFF IT DRIPS EVEN WHEN CLAMPED OFF. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317333 ↗MalfunctionDec 3, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DURING THERAPY B BRAUN IV TUBING DISCONNECTED WHILE A PATIENT WAS WAITING IN PRE-OP FOR THEIR PROCEDURE. THE PATIENT STATED THEY DID NOT STRETCH OR REACH FOR ANYTHING TO AID IN ITS DISCONNECTION. THE PATIENT WAS NOT HARMED, BUT IT HAPPENED WHILE THEY WERE RESTING IN THE PRE-OP BED PRIOR TO THEIR PROCEDURE. FORTUNATELY, THEY UTILIZED THE CALL-LIGHT TO GET OUR ATTENTION ABOUT A "WET SENSATION," WHICH WAS BLOOD COMING FROM THE TUBING DUE TO IT BEING DISCONNECTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23704240 ↗MalfunctionJul 3, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: REPORTED ISSUE: FOREIGN PARTICULE IN UNIVERSAL SPIKE PORTON. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19665489 ↗MalfunctionNov 15, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET CAME APART AT DISTAL PORT THAT CONNECTS TO IV CATHETER, AND BLOOD LEAKED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 12811055 ↗
Other Set, administration, intravascular devices
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- 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 · each recall links to the FDA recall notice
- 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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