Blood Administration Set 375154Recalls & reported problems
B. Braun Medical Inc. · Gravity Blood Administration Set with hand pump and 1 ULTRASITE® 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046964182990), received between Feb 15, 2018 and Feb 15, 2018 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 Leak8
Patient problems
- No Consequences Or Impact To Patient6
- No Patient Involvement2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2. DURING PRIMING, THE IV SET LEAKED AT THE LOWER HUB. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274194 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: DURING PRIMING, THE IV SET LEAKED AT THE LOWER HUB. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274192 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE IV SET LEAKED LACTATED RINGERS SOLUTION AT THE Y-PORT. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274190 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IV SET LEAKED LACTATED RINGERS AT THE Y-SITE. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274188 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: DURING PRIMING, THE NURSE OBSERVED LEAKING OF LACTACED RINGERS AT THE LOWER Y-PORT. THE NURSE WAS ABLE TO START ADMINISTRATION WITH ANOTHER BLOOD SET. NO DELAY IN THERAPY. NO INJURIES REPORTED.
Patient problems: No Patient Involvement
MAUDE report 7274187 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: LEAKAGE OF LACTATED RINGERS OCCURRED. NO PATIENT INJURY. LIMITED INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274186 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: DURING PRIMING, THE NURSE OBSERVED LEAKING OF LACTACED RINGERS AT THE LOWER Y-PORT. THE NURSE WAS ABLE TO START ADMINISTRATION WITH ANOTHER BLOOD SET. NO DELAY IN THERAPY. NO INJURIES REPORTED.
Patient problems: No Patient Involvement
MAUDE report 7274183 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE IV SET BROKE BETWEEN THE Y CONNECTORS WITH UNKOWN FLUID IN THE TUBING. NO PAITENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274180 ↗
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.
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