Blood Administration Set V2400Recalls & reported problems
B. Braun Medical Inc. · Gravity Blood Administration Set with No Injection Site · Class 2
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04046964188596), received between Mar 7, 2017 and Jul 2, 2019 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak6
- Gas Output Problem1
- Infusion or Flow Problem1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER HAD TWO INCIDENCES OF FINDING A HOLE IN THE TUBING THAT IS BELOW THE FILTER. BOTH WERE NOTED WITHIN THE FIRST 15 MINUTES OF THE BLOOD TRANSFUSION. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8753617 ↗MalfunctionJul 2, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER HAD TWO INCIDENCES OF FINDING A HOLE IN THE TUBING THAT IS BELOW THE FILTER. BOTH WERE NOTED WITHIN THE FIRST 15 MINUTES OF THE BLOOD TRANSFUSION. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8753616 ↗MalfunctionJun 19, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER REPORTS THAT THE BLOOD SET SPIKE IS FALLING OUT OF PLASMA BAG CAUSING A LOSS OF PLASMA. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8714481 ↗MalfunctionJun 19, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER REPORTS THAT THE BLOOD SET SPIKE IS FALLING OUT OF PLASMA BAG CAUSING A LOSS OF PLASMA. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8714478 ↗MalfunctionMar 8, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 2. IV SPIKE FELL OUT OF THE IV BAG DURING BLOOD TRANSFUSION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6387626 ↗MalfunctionMar 8, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 1: IV SPIKE FELL OUT OF THE IV BAG DURING BLOOD TRANSFUSION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6387604 ↗MalfunctionMar 7, 2017Gas Output Problem; Infusion or Flow Problem; Gas Output Problem; Infusion or Flow Problem
AS REPORTED BY USER FACILITY: AIR PASSING IN THE IV INFUSION OF PACKED RED BLOOD CELLS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6384123 ↗
Other Set, blood transfusion devices
- CLEARLINK 2C8750Baxter Healthcare Corporation · Set, blood transfusion176 reports
- Blood Administration Set V2500B. Braun Medical Inc. · Set, blood transfusion1 recall2 reports
- CLEARLINK 4C8723Baxter Healthcare Corporation · Set, blood transfusion1 death30 reports
- INTERLINK 2C6750HBaxter Healthcare Corporation · Set, blood transfusion18 reports
- INTERLINK 2C6700Baxter Healthcare Corporation · Set, blood transfusion8 reports
- Baxter 2C7627Baxter International Inc. · Set, blood transfusion7 reports
- CLEARLINK 2C8720Baxter Healthcare Corporation · Set, blood transfusion5 reports
- INTERLINK 2C6723Baxter International Inc. · Set, blood transfusion5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.