IV Administration Set 352643Recalls & reported problems
B. Braun Medical Inc. · IV ADMIN 15D W/2 SAFEDAY & 0.2 FILTER · 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046955594757), received between Jan 7, 2022 and Jun 1, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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/Splash3
- Air/Gas in Device2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: THE TUBING SPLIT DURING CHEMO INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354702 ↗MalfunctionApr 1, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION CONTAMINATE IN THE CHAMBER. DETAILED INQUIRY DESCRIPTION OPENED THE PACKAGE AND IT "HAD SOME REALLY GROSS LOOKING STUFF ON/IN THE CHAMBER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21738265 ↗MalfunctionJan 24, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: AIR IN TUBING, SALINE STILL LEFT IN BAG. AIR VENT WAS CLOSED ON DRIP CHAMBER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21228738 ↗MalfunctionOct 7, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION SIGNIFICANT AIR IN LINE WHILE INFUSING BETWEEN THE BAG AND PUMP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20384213 ↗MalfunctionMay 17, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: IV SET LEAKED AT FILTER. DETAILED INQUIRY DESCRIPTION ONE OF THE FILTERED TUBING REF# (B)(6). LEAKING FROM THE FILTER DURING CHEMO ADMINISTRATION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19344536 ↗MalfunctionJan 7, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THE IV SET LEAKED CHEMO AT THE FILTER CONNECTION. PATIENT STATED THAT HE NOTED A SMALL AMOUNT OF FLUID ON CHAIRSIDE TABLE AND BROUGHT IT TO THE NURSE'S ATTENTION. NURSE STATED THAT IT APPEARED TO COME FROM IN-LINE FILTER OF TUBING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13191458 ↗
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 · 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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