Backcheck Valve 415062Recalls & reported problems
B. Braun Medical Inc. · Normally Closed Check Valve · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 04022495238337), received between Dec 12, 2019 and May 9, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device5
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION UMMC PEDS ICU AIR IN LINE ALARM DETAILED INQUIRY DESCRIPTION TPN TRANSFUSING; ASV BEING USED; AIR IN LINE ALARM WITH VISIBLE AIR BUBBLE; RESOLVED WITH TROUBLESHOOTING NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19281661 ↗MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: VANCOMYCIN ADMINISTERED WITH ASV; AIR ACCUMULATION ALARM THAT WAS RESOLVED WITH TROUBLESHOOTING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19281508 ↗MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION AIR IN LINE DETAILED INQUIRY DESCRIPTION VANCOMYCIN BEING ADMINISTERED; ASV IN USE; ACCUMULATED AIR IN LINE ALARM; TROUBLESHOOTING RESOLVED NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19280818 ↗MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: AIR IN LINE ALARM. DETAILED INQUIRY DESCRIPTION PROP 1000MG/100ML DOSE 25MCG/KG/MIN TRANSFUSING; ASV BEING USED; AIL ALARM TRIGGED, TROUBLESHOOTING RESOLVED ISSUE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19280736 ↗MalfunctionDec 8, 2022Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: "OUR NURSES ARE REPORTING ERRORS WITH THE B BRAUN MACHINES. IT IS GIVING THEM RECURRING ERRORS WITH IVIGS AND THE ERROR MESSAGE IS "UPSTREAM OCCLUSION". THEY TRY MULTIPLE METHODS TO TRY TO CLEAR IT AND IT IS DELAYING PATIENT CARE. ALSO SOME MEDICATIONS CREATE BUBBLES AND AN ERROR "EXCEEDED AIR LIMIT" COMES UP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15947385 ↗MalfunctionMay 6, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE PATIENT: "AS I WAS PRIMING MY NEW EXTENSION SETS FOR THE WEEK, I ONCE AGAIN HAD THE LIGHT GREEN FEMALE LUER ATTACHMENT UNCAPPED BEFORE OPENING THE PACKAGE ON THE 6" Y EXTENSION. I'VE ALSO EXPERIENCED MILD LEAKING WHEN INFUSING BETWEEN THE GREEN FEMALE LUER AND BOTH THE ULTRASITE (415110) OR THE BACKCHECK FLOW VALVE (415062)." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11786986 ↗MalfunctionDec 12, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: DETAILS OF ISSUE: THE NURSE REPORTED A LEAK OF 5-FU: "IT WAS LEAKING FROM THE LITTLE PIECE CONNECTED ON THE TUBING BETWEEN BAG AND PUMP. THE LEAK CAUSED CONTAMINATION OF THE BAG AND PUMP." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9457802 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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