Caresite® 470116Recalls & reported problems
B. Braun Medical Inc. · Gravity Burette Set with 1 CARESITE® 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 04046964183973), received between Mar 21, 2017 and Jun 4, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (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
- Air/Gas in Device1
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Non specific EKG/ECG Changes1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: THE DEPARTMENT CLAIMS THAT THE ITEM IS CREATING AIR BUBBLES IN THE LINE. SHANTA SENT ME THE SUB TO LOOK AT WITH DR. ROBINSON FROM THE ANESTHESIA TEAM. UNFORTUNATELY THE SUB #407116 ISN'T ACCEPTABLE. WHEN TESTED WE FOUND THAT THERE'S OPPORTUNITY FOR AIR TO TRAVEL THROUGH THE TUBING ONCE THE BURETROL RUNS DRY. "THE DEPARTMENT CLAIMS THAT THE ITEM IS CREATING AIR BUBBLES IN THE LINE." NO INJURY REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19460990 ↗MalfunctionMar 21, 2017Infusion or Flow Problem; Infusion or Flow Problem
AS REPORTED BY USER FACILITY: AIR IN LINE DURING USE. AIR WAS INTRODUCED INTO THE PATIENT CAUSING ELEVATED T-WAVE REQUIRED STAY OVERNIGHT AND OBSERVATION.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 6420237 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.