Caresite® 470103Recalls & reported problems
B. Braun Medical Inc. · CARESITE® Needleless Connector, 8" Small Bore Extension Set · Class 2
All models of Caresite (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04046964298592), received between Feb 8, 2019 and Feb 17, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak5
- Leak/Splash2
- Contamination /Decontamination Problem1
- Device Alarm System1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Blood Loss1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): PATIENT WAS INFUSING TPN BASICS SOLUTION. NURSE NOTED DISCOLORATION / SEDIMENT IN FILTER OF TUBING. IMPACT TO PATIENT: DELAY IN TREATMENT. ACTION(S) TAKEN TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT). IV RATE 59.7ML/HR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24371709 ↗MalfunctionApr 2, 2025Device Alarm System; Device Alarm System
AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: IV LIPID TUBING CONSTANTLY BEEPING AIR IN LINE, WHEN INSPECTED THERE WAS NO AIR OR BUBBLES IN LIPID TUBING. TRIED DIFFERENT PUMP AND NEW TUBING. PROBLEM UNABLE TO BE RESOLVED SO LIPIDS SHUT OFF FOR THE NIGHT SHIFT. MEDICAL SERVICE MADE AWARE AND OKAY WITH PATIENT NOT RUNNING LIPIDS FOR 12 HOURS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751200 ↗MalfunctionJan 28, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET LEAKED BLOOD. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13385293 ↗MalfunctionDec 27, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE NURSE FOUND THE EXTENSION TUBE AND NEEDLE-FREE SEPARATED, AND BLOOD OUTFLOW AND SPLASHED IN THE INFANT'S INCUBATOR. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13090732 ↗MalfunctionJun 21, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: "THE RN HAS CONFIRMED THAT THE CARESITE AND CATHETER WAS CONNECTED TIGHTLY BEFORE USE, BUT ABOUT HALF A DAY AFTER USING IT ON THE PATIENT, IT SEPARATED AND CAUSED THE PATIENT'S BLOOD TO FLOW OUT." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12037019 ↗MalfunctionJun 14, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: END USER REPORTS, "AFTER CONNECTING THE 3ML EMPTY NEEDLE (BD ECLIPSE 3ML), LEAKAGE OCCURRED WHEN THE NURSE PUSH THE MEDICINE." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11990046 ↗MalfunctionJun 14, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: END USER REPORTS, "THE RN HAS CONFIRMED THAT THE CARESITE AND CATHETER WAS TIGHTENED BEFORE USE, BUT ABOUT HALF A DAY AFTER USING IT ON THE PATIENT, IT SEPARATED AND CAUSED THE PATIENT'S BLOOD TO FLOW OUT." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11990045 ↗MalfunctionJun 14, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: END USER REPORTS, "AFTER CONNECTING THE 3ML EMPTY NEEDLE (BD ECLIPSE 3ML), LEAKAGE OCCURRED WHEN THE NURSE PUSH THE MEDICINE." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11990043 ↗MalfunctionFeb 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE PRODUCT LEAKED BLOOD. NO INJURY REPORTED.
Patient problems: Blood Loss
MAUDE report 8320125 ↗
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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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