Caresite® 470108Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04046964093753), received between Dec 21, 2016 and Sep 30, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  AS REPORTED, IN ER DEPARTMENT, AFTER DRAWING BLOOD FROM THE IV, VACUTAINER WAS DISCONNECTED FROM IV EXTENSION SET AND BLOOD CONTINUED TO FLOW OUT OF EXTENSION SET CONNECTED TO IV CATHETER. THIS WAS BECAUSE A PIECE OF THE VACUTAINER BROKE OFF IN THE HUB OF THE EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20337804 ↗
• MalfunctionJan 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  EVENT 1: BLOOD LEAKAGE OCCURRED FROM THE EXTENSION SET. AS REPORTED BY THE USER FACILITY: "IT APPEARED THAT THE RUBBER PORTION OF THE CARESITE VALVE BECAME DISLODGED," CAUSING BLOOD LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11196418 ↗
• MalfunctionJan 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  EVENT 3: BLOOD LEAKAGE OCCURRED FROM THE EXTENSION SET. AS REPORTED BY THE USER FACILITY: "IT APPEARED THAT THE RUBBER PORTION OF THE CARESITE VALVE BECAME DISLODGED," CAUSING BLOOD LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11196361 ↗
• MalfunctionJan 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  EVENT 2: BLOOD LEAKAGE OCCURRED FROM THE EXTENSION SET. AS REPORTED BY THE USER FACILITY: "IT APPEARED THAT THE RUBBER PORTION OF THE CARESITE VALVE BECAME DISLODGED," CAUSING BLOOD LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11196352 ↗
• MalfunctionDec 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  EVENT 3: AS REPORTED BY THE USER FACILITY: "WHEN CONNECTING THE TUBING, THERE IS NO TIGHTNESS. BLOOD FLOWS AT THE LEVEL OF THE SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020326 ↗
• MalfunctionDec 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  EVENT 2: AS REPORTED BY THE USER FACILITY: "WHEN CONNECTING THE TUBING, THERE IS NO TIGHTNESS. BLOOD FLOWS AT THE LEVEL OF THE SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020324 ↗
• MalfunctionDec 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  EVENT 1: AS REPORTED BY THE USER FACILITY: "WHEN CONNECTING THE TUBING, THERE IS NO TIGHTNESS. BLOOD FLOWS AT THE LEVEL OF THE SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020322 ↗
• MalfunctionFeb 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: DURING THE FIRST 15 MINUTES OF THE BLOOD TRANSFUSION, NO ABNORMALITIES WERE NOTED. HOWEVER, 30 MINUTES LATER, THE PRODUCT LEAKED. BLOOD WAS OBSERVED AT THE ANTI-REFLUX VALVE. THE TRANSFUSION WAS STOPPED, THE DEVICE WAS CHANGED, AND THE TRANSFUSION WAS RESUMED WITHOUT ISSUES.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 9699370 ↗
• MalfunctionFeb 11, 2020Improper Flow or Infusion; Improper Flow or Infusion

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THAT ADDITIONAL PRIMING WITH SALINE IS DONE DUE TO AIR BACK FLOWING INTO THE TUBING AFTER PRIMING IT INITIALLY. ALSO THE CLAMP IS HARDER TO CLOSE. DETAILS OF THE REPORT: "EVEN AFTER PRIMING WITH MORE SALINE THAN USUAL THE NURSES ARE HAVING TO CLAMP OFF THE TUBING TO PREVENT AIR BACKFLOW INTO THE PATIENTS' VEINS WHICH WASN'T AN ISSUE WITH THE OLD TUBING. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9694005 ↗
• MalfunctionDec 21, 2016Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EXTENSION SET TUBE BROKE AT LUER END, DURING BLOOD INFUSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6196303 ↗