IV Administration Set 352601Recalls & reported problems
B. Braun Medical Inc. · Primary Gravity IV Set, 0 Injection Sites · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964181801), received between Jul 25, 2017 and Oct 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: PRODUCT CONCERN: IV SET HAD FOREIGN MATTER INSIDE THE STERILE TUBING APPEARED BLACK AND SYRUPY. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350180 ↗MalfunctionJul 25, 2017Infusion or Flow Problem; Infusion or Flow Problem
AS REPORTED BY THE USER FACILITY: INCREASED BUBBLES NOTED IN IV SET WHEN INFUSING IVIG, CAUSING AIR IN LINE DURING USE. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6740540 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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