Blood Administration Set 354217Recalls & reported problems
B. Braun Medical Inc. · Gravity Blood Administration Set with 1 CARESITE® Injection Site · Class 2
All models of Blood Administration Set (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964182297), received between Mar 27, 2024 and Jul 11, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE SET WAS BEING USED TO ADMINISTER BLOOD TO A PATIENT, IT WAS SET UP IN THE BLOOD WARMER AND WHEN PRIMING THE LINE WITH SALINE IT WAS DISCOVERED THAT THE CONNECTOR WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22477940 ↗MalfunctionMar 27, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DESCRIPTION OF THE PATIENT EVENT: (B)(4) BACKCHECK VALVE BROKE AND DISCONNECTED DURING BLOOD INFUSION. DESCRIBE TYPE OF INTERVENTION: PATIENT DID NOT RECEIVE FULL UNIT OF BLOOD DUE TO DISCONNECTION WAS THERAPY INCOMPLETE, INCORRECT OR INTERRUPTED YES. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18985210 ↗
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
- 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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