Blood Administration Set 490530Recalls & reported problems
B. Braun Medical Inc. · Y-TYPE BLOOD SET, 3 CARSITE LADS, 146 IN · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04046955203321), received between Oct 17, 2019 and Oct 17, 2019 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (11 reports).
2 FDA recall records 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. How this data works · Data updated Oct 13, 2026.
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-0618-2026 · Root cause: Process control · FDA record ↗
- Nov 20, 2019Terminated
Potential for leakage at the joint between the blood filters and tubing
Z-0939-2020 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak11
Patient problems
- No Known Impact Or Consequence To Patient11
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 8: CHIEF CRNA STATES, "CUSTOM BLOOD SET TUBING #490530 IS LEAKING AT Y JUNCTION." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9202623 ↗MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: CHIEF CRNA STATES, "CUSTOM BLOOD SET TUBING #490530 IS LEAKING AT Y JUNCTION." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9202621 ↗MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: CHIEF CRNA STATES, "CUSTOM BLOOD SET TUBING #490530 IS LEAKING AT Y JUNCTION." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9202618 ↗MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: CHIEF CRNA STATES, "CUSTOM BLOOD SET TUBING #490530 IS LEAKING AT Y JUNCTION." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9202617 ↗MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 11: CHIEF CRNA STATES, "CUSTOM BLOOD SET TUBING #490530 IS LEAKING AT Y JUNCTION." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9202616 ↗MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 5: CHIEF CRNA STATES, "CUSTOM BLOOD SET TUBING #490530 IS LEAKING AT Y JUNCTION." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9202615 ↗MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: CHIEF CRNA STATES, "CUSTOM BLOOD SET TUBING #490530 IS LEAKING AT Y JUNCTION." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9202614 ↗MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 6: CHIEF CRNA STATES, "CUSTOM BLOOD SET TUBING #490530 IS LEAKING AT Y JUNCTION." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9202613 ↗MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 9: CHIEF CRNA STATES, "CUSTOM BLOOD SET TUBING #490530 IS LEAKING AT Y JUNCTION." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9202612 ↗MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 10: CHIEF CRNA STATES, "CUSTOM BLOOD SET TUBING #490530 IS LEAKING AT Y JUNCTION." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9202611 ↗MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 7: CHIEF CRNA STATES, "CUSTOM BLOOD SET TUBING #490530 IS LEAKING AT Y JUNCTION." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9202610 ↗
Other Stopcock, i.V. Set devices
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- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- IV Administration Set 490067B. Braun Medical Inc. · Stopcock, i.V. Set1 recall9 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 reports
- IV Administration Set 490432B. Braun Medical Inc. · Stopcock, i.V. Set1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.