IV Administration Set V1415-15Recalls & reported problems
B. Braun Medical Inc. · Primary Gravity IV Set, 1 Non-Needle-Free Injection Site · Class 2
- 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 04046964188213), received between Apr 24, 2019 and Jun 13, 2022 — 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.
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Inaccurate Flow Rate1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2022Inaccurate Flow Rate; Inaccurate Flow Rate
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: AFTER THE DRIP RATE IS SET, THE RATE GRADUALLY SLOWS DOWN UNTIL IT STOPS DRIPPING. THE LINE GETS FLATTENED BEHIND THE ROLLER AND STOPS THE FLOW. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14674370 ↗MalfunctionApr 24, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: END USER NOTED PARTICULATE MATERIAL FLOATING WITHIN A BAG DURING INFUSION ON A PATIENT. CUSTOMER STATED THAT THEY OBSERVED "10-15 SMALL PARTICLES" THAT WERE FLOATING AND "WHITE/TRANSLUCENT" IN COLOR. THE VOLUME OF THE BAG WAS 1000ML, AND 600ML HAD BEEN INFUSED BEFORE THE PARTICLES WERE DISCOVERED. NOTHING HAD BEEN ADDED TO THE BAG PRIOR TO INFUSION. NO INJURY REPORTED. IT SHOULD BE NOTED THAT THIS REPORT IS SPECIFIC TO THE IV ADMINISTRATION SET.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8546995 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.