Blood Administration Set 490314Recalls & reported problems
B. Braun Medical Inc. · Y-TYPE BLOOD SET, 106 IN. · Class 2
All models of Blood Administration Set (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04046964527180), received between Feb 15, 2018 and Sep 17, 2019 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (19 reports).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Nov 20, 2019Terminated
Potential for leakage at the joint between the blood filters and tubing
Z-0937-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak19
- Contamination /Decontamination Problem1
Patient problems
- No Consequences Or Impact To Patient10
- No Known Impact Or Consequence To Patient10
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET IS LEAKING WHERE THE TUBING ENTERS THE FILTER CHAMBER. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9075110 ↗MalfunctionSep 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT THE BLOOD SET LEAKED WHERE THE TUBING ENTERS THE DRIP CHAMBER. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8980195 ↗MalfunctionSep 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE BLOOD SET LEAKED WHERE THE TUBING ENTERS THE DRIP CHAMBER. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8980194 ↗MalfunctionSep 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE BLOOD SET LEAKED WHERE THE TUBING ENTERS THE DRIP CHAMBER. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8980193 ↗MalfunctionSep 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 5: IT WAS REPORTED THAT THE BLOOD SET LEAKED WHERE THE TUBING ENTERS THE DRIP CHAMBER. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8980192 ↗MalfunctionSep 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: IT WAS REPORTED THAT THE BLOOD SET LEAKED WHERE THE TUBING ENTERS THE DRIP CHAMBER. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8980191 ↗MalfunctionSep 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 7: IT WAS REPORTED THAT THE BLOOD SET LEAKED WHERE THE TUBING ENTERS THE DRIP CHAMBER. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8980189 ↗MalfunctionSep 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 6: IT WAS REPORTED THAT THE BLOOD SET LEAKED WHERE THE TUBING ENTERS THE DRIP CHAMBER. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8980188 ↗MalfunctionSep 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 8: IT WAS REPORTED THAT THE BLOOD SET LEAKED WHERE THE TUBING ENTERS THE DRIP CHAMBER. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8980187 ↗MalfunctionAug 21, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE PRODUCT IS LEAKING. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8917063 ↗MalfunctionAug 6, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS STATED THAT THE PATIENT NOTICED THE FOREIGN BODY IN THE TUBING, AND THAT IT "LOOKED LIKE AN ANT". INFUSION WAS IMMEDIATELY STOPPED AND THE TUBING REMOVED. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7751470 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT THE SET LEAKED DURING USE WITH LACTATED RINGERS AND/OR NORMAL SALINE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7275060 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: IT WAS REPORTED THAT THE SET LEAKED DURING USE WITH LACTATED RINGERS AND/OR NORMAL SALINE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7275058 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 5: IT WAS REPORTED THAT THE SET LEAKED DURING USE WITH LACTATED RINGERS AND/OR NORMAL SALINE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7275057 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 8: IT WAS REPORTED THAT THE SET LEAKED DURING USE WITH LACTATED RINGERS AND/OR NORMAL SALINE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7275054 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE SET LEAKED DURING USE WITH LACTATED RINGERS AND/OR NORMAL SALINE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7275053 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE SET LEAKED DURING USE WITH LACTATED RINGERS AND/OR NORMAL SALINE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7275052 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 7: IT WAS REPORTED THAT THE SET LEAKED DURING USE WITH LACTATED RINGERS AND/OR NORMAL SALINE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7275051 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 6: IT WAS REPORTED THAT THE SET LEAKED DURING USE WITH LACTATED RINGERS AND/OR NORMAL SALINE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7275050 ↗MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 9: IT WAS REPORTED THAT THE SET LEAKED DURING USE WITH LACTATED RINGERS AND/OR NORMAL SALINE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7275048 ↗
Other Set, administration, intravascular devices
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- 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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