Blood Administration Set 490438Recalls & reported problems
B. Braun Medical Inc. · Y-TYPE BLOOD SET,HAND PUMP, 146 IN. · Class 2
All models of Blood Administration Set (24)
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.
Quick summary
This B. Braun blood administration set is a Y-type blood set with a hand pump for delivering blood and IV fluids. Its 37 reports mostly describe tubing cracking or breaking at various points, and leaking or splashing blood and fluid; no deaths or injuries are reported. One open recall, from October 2025, concerns medication flowing backward from a piggyback IV container into the primary one, and the set not priming because of an occlusion.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 04046964833441), received between Apr 26, 2017 and Aug 19, 2025 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (20 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-0619-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash20
- Fluid/Blood Leak15
- Contamination /Decontamination Problem1
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Known Impact Or Consequence To Patient12
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: IV TUBING BROKE AT VARIOUS PARTS. DETAILED INQUIRY DESCRIPTION: CUSTOMER HAS HAD A SLEW OF IV TUBING THAT BROKE AT VARIOUS PARTS OF THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22842977 ↗MalfunctionMay 5, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION: 4 SETS LEAKING OR BROKEN AT THE BACK CHECK VALVE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14285531 ↗MalfunctionMay 5, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 3: BRIEF INQUIRY DESCRIPTION: 4 SETS LEAKING OR BROKEN AT THE BACK CHECK VALVE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14285502 ↗MalfunctionMay 5, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: BRIEF INQUIRY DESCRIPTION: 4 SETS LEAKING OR BROKEN AT THE BACK CHECK VALVE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14285496 ↗MalfunctionMay 5, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 4: BRIEF INQUIRY DESCRIPTION: 4 SETS LEAKING OR BROKEN AT THE BACK CHECK VALVE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14285429 ↗MalfunctionNov 17, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE HAND PUMP LEAKED WHEN FORCE WAS APPLIED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12832719 ↗MalfunctionNov 17, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE HAND PUMP LEAKED WHEN FORCE WAS APPLIED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12832716 ↗MalfunctionNov 17, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT MULTIPLE BLOOD SETS HAVE BEEN CRACKED BETWEEN THE BACKCHECK VALVE AND THE UPPER Y-SITE RESULTING IN LEAKAGE AS THE PREOP NURSES REMOVE THEM FROM THE POUCH. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12832691 ↗MalfunctionNov 17, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT MULTIPLE BLOOD SETS HAVE BEEN CRACKED BETWEEN THE BACKCHECK VALVE AND THE UPPER Y-SITE RESULTING IN LEAKAGE AS THE PREOP NURSES REMOVE THEM FROM THE POUCH. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12832689 ↗MalfunctionNov 17, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 4: IT WAS REPORTED THAT MULTIPLE BLOOD SETS HAVE BEEN CRACKED BETWEEN THE BACKCHECK VALVE AND THE UPPER Y-SITE RESULTING IN LEAKAGE AS THE PREOP NURSES REMOVE THEM FROM THE POUCH. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12832688 ↗MalfunctionNov 17, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT MULTIPLE BLOOD SETS HAVE BEEN CRACKED BETWEEN THE BACKCHECK VALVE AND THE UPPER Y-SITE RESULTING IN LEAKAGE AS THE PREOP NURSES REMOVE THEM FROM THE POUCH. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12832687 ↗MalfunctionSep 26, 2021Leak/Splash; Leak/Splash
EVENT 3: AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE TUBING LEAKED DURING USE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12530996 ↗MalfunctionSep 26, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2. IT WAS REPORTED THAT THE TUBING LEAKED DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12530995 ↗MalfunctionSep 26, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 3. IT WAS REPORTED THAT THE TUBING LEAKED DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12530994 ↗MalfunctionSep 26, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1 IT WAS REPORTED THAT THE TUBING LEAKED DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12530993 ↗MalfunctionSep 26, 2021Leak/Splash; Leak/Splash
EVENT 1 AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE TUBING LEAKED DURING USE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12530992 ↗MalfunctionSep 26, 2021Leak/Splash; Leak/Splash
EVENT 2: AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE TUBING LEAKED DURING USE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12530991 ↗MalfunctionSep 26, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 4 IT WAS REPORTED THAT THE TUBING LEAKED DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12530990 ↗MalfunctionSep 26, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 5. IT WAS REPORTED THAT THE TUBING LEAKED DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12530989 ↗MalfunctionSep 3, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE BLOOD SET LEAKED FROM THE SEAL OF THE HAND PUMP. TUBING WAS CHANGED DURING THE CASE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12422230 ↗MalfunctionJun 10, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: END USER REPORTS THAT THE BLOOD SET DETACHED AND LEAKED BLOOD. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11973339 ↗MalfunctionJun 10, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: END USER REPORTS, LEAKING AT BOTTOM OF HAND PUMP WHILE SQUEEZING, REQUIRED SET CHANGE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11973338 ↗MalfunctionOct 10, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
THIS REPORT IS BEING FILED DUE TO RETAIN SAMPLES FAILING VISUAL INSPECTION DURING TESTING: BASED ON THE EVALUATION RESULTS THE MANUFACTURING SITE STATED THAT ONE (1) OUT OF FIVE (5) UNITS WAS FOUND TO HAVE FOREIGN MATTER IN THE FLUID PATH.
Patient problems: No Patient Involvement
MAUDE report 9176307 ↗MalfunctionJul 16, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: BLOOD SET TUBS ARE LEAKING EXCESSIVELY AND FITTINGS ARE SNAPPING. FLUID IS LEAKING AT THE BIFURCATION AND/OR THE TUBING AT THE BIFURCATION COMPLETELY COMES APART. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8793008 ↗MalfunctionApr 25, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: USER REPORTED SETS WERE LEAKING AT THE BOTTOM OF THE FILTER CHAMBER AND DETACHING IN VARIOUS PLACES. NO INJURIES WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8548823 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page