Blood Administration Set 354218Recalls & reported problems
B. Braun Medical Inc. · Gravity Blood Administration Set with hand pump and 1 CARESITE® Injection Site · Class 2
All models of Blood Administration Set (24)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04046964182310), received between Nov 23, 2016 and May 14, 2021 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak12
- Device Operates Differently Than Expected3
- Device Contamination with Chemical or Other Material1
Patient problems
- No Consequences Or Impact To Patient13
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE TUBING SEPARATED AT A CONNECTION AND BLOOD LEAKED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11824545 ↗MalfunctionMay 14, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE TUBING SEPARATED AT A CONNECTION AND BLOOD LEAKED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11824538 ↗MalfunctionApr 5, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THAT THE PRIMIMG CHAMBER IS SEPARATING AND LEAKED DURING USE. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8486566 ↗MalfunctionFeb 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT BOTH THE BLOOD FILTER AND THE HAND PUMP ON THE CARESITE Y-TYPE BLOOD SET ARE CRACKING OR COMING APART DURING PATIENT CARE IN SURGERY. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8320129 ↗MalfunctionFeb 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT BOTH THE BLOOD FILTER AND THE HAND PUMP ON THE CARESITE Y-TYPE BLOOD SET ARE CRACKING OR COMING APART DURING PATIENT CARE IN SURGERY. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8320128 ↗MalfunctionFeb 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 5: IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT BOTH THE BLOOD FILTER AND THE HAND PUMP ON THE CARESITE Y-TYPE BLOOD SET ARE CRACKING OR COMING APART DURING PATIENT CARE IN SURGERY. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8320127 ↗MalfunctionFeb 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT BOTH THE BLOOD FILTER AND THE HAND PUMP ON THE CARESITE Y-TYPE BLOOD SET ARE CRACKING OR COMING APART DURING PATIENT CARE IN SURGERY. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8320126 ↗MalfunctionFeb 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT BOTH THE BLOOD FILTER AND THE HAND PUMP ON THE CARESITE Y-TYPE BLOOD SET ARE CRACKING OR COMING APART DURING PATIENT CARE IN SURGERY. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8320124 ↗MalfunctionApr 21, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A FOREIGN FIBER (APPEARED TO BE A HAIR) WAS SEEN IN THE BLOOD TUBING SET. THE HAIR WAS NOTICED PARTIALLY INSIDE THE FILTER AND PARTIALLY OUTSIDE THE FILTER DURING PRIMING. NO INJURIES REPORTED. THE PRODUCT WAS NOT USED ON A PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7449672 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: LEAKING OCCURRED DURING USE. NO PATIENT INJURY. LIMITED INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274184 ↗MalfunctionJan 22, 2018Fluid/Blood Leak; Fluid/Blood Leak
DURING THE BLOOD ADMINISTRATION, THE HAND PUMP LEAKED. LIMITED INFORMATION PROVIDED. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7210059 ↗MalfunctionJun 16, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: DURING USE THE Y SET LEAKED BLOOD. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6648906 ↗MalfunctionDec 21, 2016Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: BLOOD SET FILTER CRACKED AND LEAKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6196338 ↗MalfunctionNov 29, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: REPORTS NURSE ATTEMPTED TO ADMINISTER SODIUM CHLORIDE TO PATIENT AND NOTICED A LEAK ON THE SIDE OF THE TUBE. THERE IS BLOOD IN THE TUBING. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6133519 ↗MalfunctionNov 29, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: REPORTS BLOOD WAS SQUIRTING OUT OF THE HAND PUMP SECTION. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6133469 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: THERE IS CRACKING JUST ABOVE THE BLOOD FILTER CAUSING LEAKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124431 ↗
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 18, 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