B.BRAUN 7B3050Recalls & reported problems
B. Braun Medical Inc. · BBRAUN MEDICAL 21G X 4.4CM WINGED INF · Class U · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This B. Braun winged infusion set is used for infusions. Reports mostly describe large air bubbles persisting in tubing during treatment, with no injuries reported. There are 40 reports, no deaths and no injuries. One recall is open, started February 2026, because the needle tip may be dull, difficult to advance, or break. Reports rose from 0 to 40 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 04046964341298), received between Jan 6, 2026 and Feb 11, 2026 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (31 reports).
1 FDA recall record 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Feb 2, 2026Class IIOpen, Classified
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Z-1481-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device31
- Break9
- Patient Device Interaction Problem9
- Material Deformation7
- Difficult to Remove1
- Labelling, Instructions for Use or Training Problem1
- Material Too Soft/Flexible1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- Pain9
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: LARGE MACROBUBBLES THROUGHOUT TREATMENT. CONNECTIONS CHECKED AND TIGHTENED AND MACROBUBBLES PERSISTED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24313164 ↗MalfunctionFeb 11, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: LARGE MACROBUBBLES THROUGHOUT TREATMENT. CONNECTIONS CHECKED AND TIGHTENED AND MACROBUBBLES PERSISTED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24313095 ↗MalfunctionFeb 7, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: LARGE MACROBUBBLES THROUGHOUT TREATMENT. CONNECTIONS CHECKED AND TIGHTENED AND MACROBUBBLES PERSISTED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24285775 ↗MalfunctionFeb 7, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: LARGE MACROBUBBLES THROUGHOUT TREATMENT. CONNECTIONS CHECKED AND TIGHTENED AND MACROBUBBLES PERSISTED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24285769 ↗MalfunctionFeb 7, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 4: LARGE MACROBUBBLES THROUGHOUT TREATMENT. CONNECTIONS CHECKED AND TIGHTENED AND MACROBUBBLES PERSISTED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24285768 ↗MalfunctionFeb 7, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: LARGE MACROBUBBLES THROUGHOUT TREATMENT. CONNECTIONS CHECKED AND TIGHTENED AND MACROBUBBLES PERSISTED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24285767 ↗MalfunctionFeb 7, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 3: LARGE MACROBUBBLES THROUGHOUT TREATMENT. CONNECTIONS CHECKED AND TIGHTENED AND MACROBUBBLES PERSISTED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24285766 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 11: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24281581 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 12: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24281556 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 8: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24281140 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 9: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24281136 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 6: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24281135 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 7: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24281124 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 10: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24281116 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 4: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280832 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 5: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280831 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280830 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 3: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280829 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280826 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 6: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279760 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 5: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279631 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 3: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279616 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 4: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279615 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279610 ↗MalfunctionFeb 6, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: LARGE AND MANY MACROBUBBLES IN ARTERIAL LINE OF DIALYSIS TUBING. CONNECTION SECURED AND TIGHTENED WITH NO RESOLUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279609 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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