CARESAFE™ 471858Recalls & reported problems
B. Braun Medical Inc. · CARESAFE EXT SET w/NR CARESITE, 8 IN. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046955238279), received between Feb 20, 2026 and Feb 20, 2026 — classified as 3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash3
- Reflux within Device3
Patient problems
- Hemorrhage/Blood Loss/Bleeding3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Leak/Splash; Reflux within Device
AS REPORTED BY THE USER FACILITY: EVENT 3: "THE PRODUCT IS BACK FLOWING TERRIBLY AND MAKING A MESS. I ORDERED THE STANDARD BORE AND SMALL BORE AND THE SAME PROBLEM HAPPENED WITH BOTH. I'VE USED 3 OUT OF EACH BOX TO MAKE SURE IT WASN'T JUST ONE BAD SET. A NURSE ALSO TRIED AND HAD THE SAME ISSUE. IT'S BACK FLOW OF BLOOD. I DISCONNECTED THE LINE, CLAMPED IT, AND THE BLOOD CAME FLOWING OUT OF END OF THE EXTENSION SET ONTO THE PATIENTS CLOTHING."
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24406323 ↗MalfunctionFeb 20, 2026Leak/Splash; Reflux within Device
AS REPORTED BY THE USER FACILITY: EVENT 2: "THE PRODUCT IS BACK FLOWING TERRIBLY AND MAKING A MESS. I ORDERED THE STANDARD BORE AND SMALL BORE AND THE SAME PROBLEM HAPPENED WITH BOTH. I'VE USED 3 OUT OF EACH BOX TO MAKE SURE IT WASN'T JUST ONE BAD SET. A NURSE ALSO TRIED AND HAD THE SAME ISSUE." "IT'S BACK FLOW OF BLOOD. I DISCONNECTED THE LINE, CLAMPED IT, AND THE BLOOD CAME FLOWING OUT OF END OF THE EXTENSION SET ONTO THE PATIENTS CLOTHING."
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24406322 ↗MalfunctionFeb 20, 2026Leak/Splash; Reflux within Device
AS REPORTED BY THE USER FACILITY: EVENT 1: "THE PRODUCT IS BACK FLOWING TERRIBLY AND MAKING A MESS. I ORDERED THE STANDARD BORE AND SMALL BORE, AND THE SAME PROBLEM HAPPENED WITH BOTH. I'VE USED 3 OUT OF EACH BOX TO MAKE SURE IT WASN'T JUST ONE BAD SET. A NURSE ALSO TRIED AND HAD THE SAME ISSUE." "IT'S BACK FLOW OF BLOOD. I DISCONNECTED THE LINE, CLAMPED IT, AND THE BLOOD CAME FLOWING OUT OF END OF THE EXTENSION SET ONTO THE PATIENTS CLOTHING."
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24406318 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.