Caresite® 354205Recalls & reported problems
B. Braun Medical Inc. · Primary Gravity IV Set with 3 CARESITE® Injection Sites · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04046964182099), received between Apr 26, 2017 and Mar 26, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Oct 29, 2025Open, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0624-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak7
- Contamination /Decontamination Problem4
- Inaccurate Flow Rate2
- Leak/Splash2
- Free or Unrestricted Flow1
- Material Deformation1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient5
- Needle Stick/Puncture1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Free or Unrestricted Flow
AS REPORTED VIA MEDWATCH NUMBER MW5183916: ROLLER CLAMPS ON GRAVITY IV TUBING NOT STOPPING INFUSION OF ORDERED MEDICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24706060 ↗MalfunctionFeb 4, 2026Inaccurate Flow Rate; Material Deformation
AS REPORTED BY THE USER FACILITY: END USER REPORTS HAVING ISSUES WITH FLOW "UNABLE TO CONTROL FLOW, TUBING COMING ATTACHED AT IV SITE, TUBING TANGLED EVERYWHERE". NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257794 ↗MalfunctionSep 25, 2024Inaccurate Flow Rate; Inaccurate Flow Rate
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: ROLLER CLAMP NOT WORKING. DETAILED INQUIRY DESCRIPTION: CUSTOMER SAYS THAT ROLLER CLAMP IS NOT WORKING. TO THE POINT, THAT SHE HAD TO CLOSE THE ROLLER CLAMP TO KEEP IT FROM FREE FLOWING. THIS CAUSED AN IV TO DRY UP RIGHT BEFORE STARTING THE PROCEDURE. CUSTOMER HAD TO START ANOTHER IV IN OR AFTER PATIENT WAS A DIFFICULT STICK. THE ROLLER CLAMP HAS NOT WORKED PROPERLY ON ANY OF THEIR TUBING.
Patient problems: Needle Stick/Puncture
MAUDE report 20303805 ↗MalfunctionMay 10, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: IT WAS REPORTED THAT THE IV ADMINISTRATION SET AND CARE SITE HAVE OIL ON THE CONNECTOR. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14348207 ↗MalfunctionMay 10, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: IT WAS REPORTED THAT THE IV ADMINISTRATION SET AND CARESITE HAVE OIL ON THE CONNECTOR. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14348201 ↗MalfunctionFeb 3, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE END USER IS EXPERIENCING PROBLEMS WITH THE PRIMARY IV PUMP SET TUBING WITH BLOOD BACKING UP INTO THE TUBING. THE STAFF ARE FINDING THAT ESTABLISHED INFUSIONS (THAT WERE APPROPRIATELY PRIMED AND INFUSING) ARE DEVELOPING A BLOOD BACK-UP TO THE PROXIMAL PORT AND LEAKING FROM THAT SITE AT TIMES. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13445976 ↗MalfunctionFeb 3, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE END USER IS EXPERIENCING PROBLEMS WITH THE PRIMARY IV PUMP SET TUBING WITH BLOOD BACKING UP INTO THE TUBING. THE STAFF ARE FINDING THAT ESTABLISHED INFUSIONS (THAT WERE APPROPRIATELY PRIMED AND INFUSING) ARE DEVELOPING A BLOOD BACK-UP TO THE PROXIMAL PORT AND LEAKING FROM THAT SITE AT TIMES. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13445966 ↗MalfunctionJul 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT PARTICLES WERE OBSERVED INSIDE THE DRIP CHAMBER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12172286 ↗MalfunctionJul 13, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: "THE FLUID FILL CHAMBER APPEARED TO HAVE CONTAMINANTS IN IT." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12157457 ↗MalfunctionFeb 16, 2021Fluid/Blood Leak; Fluid/Blood Leak
EVENT 1: AS REPORTED BY THE USER FACILITY: THE TUBING CONNECTIONS DID NOT STAY TIGHT, RESULTING IN BLOOD LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11331309 ↗MalfunctionFeb 16, 2021Fluid/Blood Leak; Fluid/Blood Leak
EVENT 2: AS REPORTED BY THE USER FACILITY: THE TUBING CONNECTIONS DID NOT STAY TIGHT, RESULTING IN BLOOD LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11331308 ↗MalfunctionAug 25, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT BLOOD LEAKED DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10451418 ↗MalfunctionSep 6, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: THE TUBING BROKE WHICH CAUSED THE CARBOPLATIN TO LEAK. NO INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7852879 ↗MalfunctionSep 6, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: THE TUBING BROKE WHICH CAUSED THE AVASTIN TO LEAK. NO INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7852874 ↗MalfunctionOct 8, 2017Fluid/Blood Leak; Fluid/Blood Leak
(B)(4). EVENT DESCRIPTION: I WAS PRIMING IV TUBING AND THE TUBING FELL APART AT A PORT CONNECTION. THE TUBING WAS NOT CONNECTED TO A PATIENT. 1 WEEK AGO I REMEMBER THE SAME TYPE TUBING FALLING APART ON A PATIENT, BLOOD STARTED BACKING UP AND RUNNING ON THE FLOOR. I DISCONNECTED TUBING AND THREW IT AWAY. NO HARM TO THAT PATIENT. AT THE TIME I THOUGHT POSSIBLY THE TUBING WAS DAMAGED DURING TRANSPORTING THE PATIENT, BUT NOW LOOKING BACK I BELIEVE THE TUBING MUST HAVE BEEN FAULTY AS WELL. NO ONE SAW THE TUBING GET DAMAGED. THERE IS ONE EVENT BEING REPORTED FOR BLOOD LEAKAGE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6927869 ↗MalfunctionOct 3, 2017Mechanical Problem; Mechanical Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT WHEN THE CLAMP IS RE-CLOSED ON THE TUBING IN THE SAME SPOT IT WAS PREVIOUSLY CLOSED, FLUID WILL CONTINUE TO RUN. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6913101 ↗MalfunctionApr 26, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE LINE WAS CLAMPED AND IT SPLIT CAUSING THE IV SET TO LEAK BLOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6522386 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.