Caresite® 470109Recalls & reported problems
B. Braun Medical Inc. · CARESITE® Needleless Connector, 6" Standard Bore Extension Set · Class 2
All models of Caresite (23)
Data updated Oct 16, 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 04046964183935), received between Dec 7, 2016 and Feb 1, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- 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.
MalfunctionFeb 1, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: REPORTED ISSUE: PATIENT HAD SALINE LOCK IN PLACE TO LEFT HAND IV. WHEN RN REMOVES IV TUBING TO SALINE LOCK PATIENT FROM THE SALINE LOCK HUB, THE HUB BACKFLOWS WITH BLOOD CAUSING THE BLOOD TO DRIP ALL OVER PATIENT PRIOR TO RN CLAMPING TUBING WITH PROVIDED CLIP. CHARGE RN ASSISTS RN IN CHANGING SALINE LOCK TO PATIENT'S IV HUB. UPON INSPECTION, IT APPEARS THAT THE "HUB STOPPER" INSIDE THE HUB LOCK IS TURNED TO THE SIDE, RESULTING IN POSSIBLE COMPROMISE OF THE BACKFLOW MECHANISM CAUSING A "FREE FLOW EFFECT".
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 16277827 ↗MalfunctionDec 7, 2016Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: LEAKING GENERAL IV SOLUTION AND BLOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6153280 ↗
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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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