Caresite® 470104Recalls & reported problems
B. Braun Medical Inc. · CARESITE® Needleless Connector, 14" Bonded 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046964115066), received between Mar 6, 2020 and Jun 12, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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
- Leak/Splash3
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Blood Loss1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE B. BRAUN AFFILIATE: COMPLAINT: DURING INFUSION, THE TUBE AND VALVE BODY BECAME DETACHED, CAUSING BLOOD TO LEAK. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19519389 ↗MalfunctionDec 5, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: COMPLAINT: A LIQUID LEAK OCCURRED. A LIQUID LEAK WAS DISCOVERED WHILE ADMINISTERING ANTI-CANCER DRUGS. AFTER THAT, THE PROBLEM WAS CONFIRMED USING PHYSIOLOGICAL SALINE AND THE PROBLEM WAS REPRODUCED. IT IS UNCLEAR WHERE THE LEAK IS COMING FROM. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18271177 ↗MalfunctionJun 20, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: WHEN THE USER TRIED TO LOCK THE SALINE SOLUTION, THE VALVE PART CAME OFF AND BLOOD LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14743416 ↗MalfunctionAug 10, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT BLOOD WAS LEAKING AROUND THE GREEN CONNECTOR. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10385465 ↗MalfunctionMar 6, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE SET LEAKED BLOOD DURING USE. NO INJURY REPORTED.
Patient problems: Blood Loss
MAUDE report 9797204 ↗
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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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