Caresite Micro™ 354268Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046955773022), received between Apr 25, 2025 and Jul 9, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CRACKED TUBING/LEAKING. DETAILED INQUIRY DESCRIPTION: THE TUBING SEEMED TO BE CRACKED/LEAKING NEAR THE HUB, THUS HAVING BLOOD LEAK OUT ONTO THE TUBING, PATIENT AND NURSE.

  Patient problems: Exposure to Body Fluids; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22457201 ↗
• MalfunctionJun 15, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION: CARESITE CAP FALLING OFF EXTENSION SET. DETAILED INQUIRY DESCRIPTION: TWO TIMES THIS WEEK, THE END CAP ON THE 8 INCH CARESITE MICRO SET WITH REMOVABLE CARESITE MICRO LUER ACCESS DEVICE AND SPIN LOCK CONNECTOR FELL OFF WHILE DRAWING LABS ON A PATIENT. IF THE END CAP IS REMOVED, THERE IS NO VALVE KEEPING THE BLOOD FLOW IN. WHEN RN WAS DRAWING LABS, THE END CAP OF THE EXTENSION SET FELL OFF CAUSING PATIENT'S BLOOD FLOWS OUT OF THE PIV. BLOOD WENT ON THE PATIENT, AND IT CAUSED A LARGE MESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208625 ↗
• MalfunctionJun 15, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: BRIEF INQUIRY DESCRIPTION CARESITE CAP FALLING OFF EXTENSION SET DETAILED INQUIRY DESCRIPTION TWO TIMES THIS WEEK, THE END CAP ON THE 8 INCH CARESITE MICRO SET WITH REMOVABLE CARESITE MICRO LUER ACCESS DEVICE AND SPIN LOCK CONNECTOR FELL OFF WHILE DRAWING LABS ON A PATIENT. IF THE END CAP IS REMOVED, THERE IS NO VALVE KEEPING THE BLOOD FLOW IN. WHEN RN WAS DRAWING LABS, THE END CAP OF THE EXTENSION SET FELL OFF CAUSING PATIENT'S BLOOD FLOWS OUT OF THE PIV. BLOOD WENT ON THE PATIENT, AND IT CAUSED A LARGE MESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208624 ↗
• MalfunctionMay 1, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CHEMO LEAKED FROM EXTENSION SET ONTO PATIENT. DETAILED INQUIRY DESCRIPTION: PATIENTS EXTENSION SET SEPARATED FROM THE PIV AND BLOOD AND CHEMO LEAKED ONTO PATIENT. PATIENT HAD DOCETAXEL CHEMOTHERAPY INFUSING WHEN THE CAP ON THE IV CATHETER BECAME DISCONNECTED FROM THE EXTENSION TUBING ON THE PATIENT'S PIV. PATIENT'S PIV THEN BACK FLOWED BLOOD ALL OVER THE PATIENT, THE INFUSION CHAIR, AND THE FLOOR. THE CHEMOTHERAPY THAT WAS INFUSING WHEN THE CAP BECAME DETACHED, LEAKED ONTO THE PATIENT'S SKIN, THE INFUSION CHAIR, AND THE FLOOR. PATIENT PUT ON HER CALL LIGHT WHEN SHE NOTICED HER IV WAS BLEEDING. WHEN WRITER WALKED IN THE ROOM, IMMEDIATELY CLAMPED PATIENT'S PIV TO STOP IT FROM FURTHER BLEEDING AND STOPPED THE PATIENT'S INFUSION PUMP TO STOP FURTHER CHEMOTHERAPY FROM LEAKING ALL OVER. CHEMO SPILL KIT WAS THEN OBTAINED, AND THE CHEMOTHERAPY WAS CLEANED UP PER PROTOCOL. CLEANED UP THE BLOOD ON THE PATIENT, CHAIR, AND FLOOR, AND WASHED PATIENT'S ARM WITH SOAPY WIPES WHERE THE CHEMOTHERAPY CAME INTO CONTACT WITH HER SKIN. OFFERED PATIENT HOSPITAL GOWN AND PANTS TO WEAR. AFTER CHEMO AND BLOOD CLEAN UP. INFUSION WAS RESTARTED WITH

  Patient problems: Chemical Exposure

  MAUDE report 21941527 ↗
• MalfunctionApr 25, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: VALVES ON EXTENSION SET ARE "POPPING" OFF OF DURING INFUSIONS OR BLOOD DRAWS. DETAILED INQUIRY DESCRIPTION: ACCOUNT IS REPORTING THAT SOME OF THE VALVES ON THE EXTENSION SETS ARE COMING OFF DURING INFUSIONS OR BLOOD DRAWS. THERE WAS LEAKING OF PATIENT'S OWN BLOOD ONTO THE PATIENT. NO BLOOD WAS FOUND ON THE STAFF MEMBER'S CLOTHING OR SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907704 ↗