Caresite Micro™ 354269Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04046955773183), received between Jun 27, 2025 and Sep 23, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (19 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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Leak/Splash

  As reported by the user facility:Upon rounding the nursing units, two issues were at play. One was improper use of the spin lock - education was provided but there was not always a connection formed by exposing the male luer tip then locking on. This led to connections that were not tight or did not fully open their blood control septum creating challenges in Rad. Education provided. The other and more frequent concern was a loose caresite micro out of the package. The product would look secure, and some clinicians did not tighten on - they reported numerous instances of returning to patient rooms to find fluid, meds, or blood all over from the caresite micro falling off. Education was provided to always ensure tight connection but request from customer to have come out of package tighter.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50870546 ↗
• MalfunctionSep 23, 2026Leak/Splash

  As reported by the user facility:Upon rounding the nursing units, two issues were at play. One was improper use of the spin lock - education was provided but there was not always a connection formed by exposing the male luer tip then locking on. This led to connections that were not tight or did not fully open their blood control septum creating challenges in Rad. Education provided. The other and more frequent concern was a loose caresite micro out of the package. The product would look secure, and some clinicians did not tighten on - they reported numerous instances of returning to patient rooms to find fluid, meds, or blood all over from the caresite micro falling off. Education was provided to always ensure tight connection but request from customer to have come out of package tighter.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50867038 ↗
• MalfunctionSep 23, 2026Leak/Splash

  As reported by the user facility:Upon rounding the nursing units, two issues were at play. One was improper use of the spin lock - education was provided but there was not always a connection formed by exposing the male luer tip then locking on. This led to connections that were not tight or did not fully open their blood control septum creating challenges in Rad. Education provided. The other and more frequent concern was a loose caresite micro out of the package. The product would look secure, and some clinicians did not tighten on - they reported numerous instances of returning to patient rooms to find fluid, meds, or blood all over from the caresite micro falling off. Education was provided to always ensure tight connection but request from customer to have come out of package tighter.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50867033 ↗
• MalfunctionSep 23, 2026Leak/Splash

  As reported by the user facility:Upon rounding the nursing units, two issues were at play. One was improper use of the spin lock - education was provided but there was not always a connection formed by exposing the male luer tip then locking on. This led to connections that were not tight or did not fully open their blood control septum creating challenges in Rad. Education provided. The other and more frequent concern was a loose caresite micro out of the package. The product would look secure, and some clinicians did not tighten on - they reported numerous instances of returning to patient rooms to find fluid, meds, or blood all over from the caresite micro falling off. Education was provided to always ensure tight connection but request from customer to have come out of package tighter.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50867027 ↗
• MalfunctionSep 8, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667628 ↗
• MalfunctionApr 29, 2026Leak/Splash

  AS REPORTED BY USER FACILITY: EVENT 1: THE END CAP (MICRO LUER ACCESS DEVICE) IS BECOMING DISCONNECTED IMMEDIATELY UPON OPENING OR DURING USE. IN MULTIPLE INSTANCES, THIS HAS RESULTED IN CONTAMINATION (E.G., SETS FALLING TO THE FLOOR) AND, IN ONE CASE, BLOOD EXPOSURE AFTER THE DEVICE WAS CONNECTED TO THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031591 ↗
• MalfunctionApr 29, 2026Leak/Splash

  AS REPORTED BY USER FACILITY: EVENT 2: THE END CAP (MICRO LUER ACCESS DEVICE) IS BECOMING DISCONNECTED IMMEDIATELY UPON OPENING OR DURING USE. IN MULTIPLE INSTANCES, THIS HAS RESULTED IN CONTAMINATION (E.G., SETS FALLING TO THE FLOOR) AND, IN ONE CASE, BLOOD EXPOSURE AFTER THE DEVICE WAS CONNECTED TO THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028260 ↗
• MalfunctionApr 29, 2026Leak/Splash

  AS REPORTED BY USER FACILITY: EVENT 3: THE END CAP (MICRO LUER ACCESS DEVICE) IS BECOMING DISCONNECTED IMMEDIATELY UPON OPENING OR DURING USE. IN MULTIPLE INSTANCES, THIS HAS RESULTED IN CONTAMINATION (E.G., SETS FALLING TO THE FLOOR) AND, IN ONE CASE, BLOOD EXPOSURE AFTER THE DEVICE WAS CONNECTED TO THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028245 ↗
• MalfunctionApr 23, 2026Leak/Splash

  AS REPORTED BY USER FACILITY: THE END CAP (MICRO LUER ACCESS DEVICE) IS BECOMING DISCONNECTED IMMEDIATELY UPON OPENING OR DURING USE. IN MULTIPLE INSTANCES, THIS HAS RESULTED IN CONTAMINATION (E.G., SETS FALLING TO THE FLOOR) AND, IN ONE CASE, BLOOD EXPOSURE AFTER THE DEVICE WAS CONNECTED TO THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966025 ↗
• MalfunctionNov 8, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE CARESITE MICRO SMALLBORE EXTENSION SET IS COMING OUT OF THE PACKAGES VERY LOOSELY ATTACHED AT THE DISTAL END WHERE LURE LOCK ATTACHMENTS CONNECTED. MULTIPLE ITEMS I HAVE HAD THE CAP FALL OFF AFTER SETTING UP AN IV OR HAD BLOOD LEAK OUT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23505310 ↗
• MalfunctionSep 12, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF ACTUAL DESCRIPTION: PEDIATRIC IV PIG TAIL CAP NOT ATTACHED WHEN PATIENT ARRIVED TO PA CU. NURSING STAFF WENT TO UNHOOK THE PATIENT'S IV AND BLOOD STARTED COMING OUT OF THE IV DUE TO THERE BEING NO CAP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23037994 ↗
• MalfunctionSep 11, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: PATIENT ARRIVED TO ER FOR LIVER LESION BIOPSY WITH CONSCIOUS SEDATION. PATIENT'S IV WAS FLUSHED AND CONNECTED TO SALINE LINE PRIOR TO PROCEDURE AND PREPPED AS USUAL. DURING PROCEDURE RN NOTICED THAT PATIENT WAS NOT ILLICITING NORMAL RESPONSE TO FENTANYL AND VERSED THAT HAD BEEN ADMINISTERED, BY THAT TIME, THE PATIENT HAD RECEIVED 125 MCG OF FENTANYL AND 2.5 MG OF VERSED. AT THAT POINT, I HAD THE PROVIDER PAUSE WHAT THEY WERE DOING AND HAD A LOOK UNDER THE DRAPE TO INSPECT THE IV TO MAKE SURE IT HADN'T BLOWN. AT THIS POINT I SAW A POOL OF BLOOD-TINGED SALINE COVERED PATIENT'S ARM AND BLANKET. THE IV EXTENSION HAD BEEN COMPLETELY DISCONNECTED FROM MICROCLAVE 1 WAY VALVE AND THE MEDS WERE BEING INFUSED OUTSIDE OF THE PATIENT. AT THIS POINT I CLEANSED THE HUB OF THE IV CATHETER AND RECONNECTED THE LINE TO THE PATIENT'S IV. PATIENT THEN WAS ADMINISTERED 50 MCG OF FENTANYL AND 1 MG OF VERSED AND PATIENT FELL INTO A MODERATE SEDATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23025349 ↗
• MalfunctionAug 27, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: CUSTOMER DESCRIPTION OF THE EVENT BEING REPORTED: RN CAME TO MY OFFICE SHOWING ME HER SCRUB PANTS COVERED IN BLOOD. SHE SAID SHE TIGHTENED THE CAP PRIOR TO PLACING THE IV AND THEN IF POPPED OFF AFTER PLACEMENT AND BLOOD STARTED LEAKING OUT ALL OVER THE PLACE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22905632 ↗
• MalfunctionAug 15, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DESCRIPTION: THE NEEDLELESS CONNECTOR (CALLED CARESITE MICRO LUER ACCESS DEVICE LAD THE PACKAGING) ON THE B BRAUN EXTENSION SET TWISTED ITSELF OFF AFTER HOOKING A SALINE FLUSH UP AND FLUSHING A PIV. THERE IS NO BACKFLOW VALVE ON THE PIV, SO IF IT WENT UNNOTICED, THE PT COULD HAVE POTENTIALLY LOST A SIGNIFICANT AMOUNT OF BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815909 ↗
• MalfunctionAug 8, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: IV TUBING MALFUNCTIONED CAUSING NUCLEAR MEDICINE TRACER TO SPILL ALL OVER PATIENT, STAFF, TREADMILL AND FLOOR DURING A STRESS TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22756019 ↗
• MalfunctionAug 6, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: WE HAD 2 IV TUBING BREAKS WHILE USING SALINE FLUSHES ON THEM CAUSING PATIENT'S BLOOD TO LEAK OUT OF IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726038 ↗
• MalfunctionAug 6, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: WE HAD 2 IV TUBING BREAKS WHILE USING SALINE FLUSHES ON THEM CAUSING PATIENT'S BLOOD TO LEAK OUT OF IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726036 ↗
• MalfunctionAug 6, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: PATIENTS IV BECAME DISCONNECTED FROM THE EXTENSION SET TO THE IV TUBING WHILE HE WAS SLEEPING, AND PATIENT BLED SIGNIFICANTLY. THE SITE FROM THE CANNULA TO THE EXTENSION TUBING WAS NOT BLEEDING, IT WAS THE SITE FROM THE EXTENSION TUBING TO THE IV TUBING WHERE THE ANTIBIOTIC HAD BEEN RUNNING. THE EXTENSION SET SHOULD HAVE A BACK FLOW VALVE TO PREVENT BLEEDING WHEN SALINE LOCKED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22726015 ↗
• InjuryJun 27, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DESCRIPTION: IV TUBING MALFUNCTIONED CAUSING NUCLEAR MEDICINE TRACER TO SPILL ALL OVER PATIENT, STAFF, TREADMILL AND FLOOR DURING A STRESS TEST. EXAM ROOM HAD TO BE CLOSED FOR THE DAY DUE TO TRACER SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345494 ↗
• MalfunctionJun 27, 2025Leak/Splash; Loose or Intermittent Connection; Reflux within Device; Leak/Splash; Loose or Intermittent Connection; Reflux within Device

  AS REPORTED BY THE USER FACILITY: DESCRIPTION: WRITER PLACED PIV ON PATIENT AND WENT TO TUBE STATION TO OBTAIN RBCS. WHEN WRITER RETURNED, PT'S PIV AND BACKED FLOWED AND WAS LEAKING BLOOD OUT OF THE CAP SECUREMENT SITE. THE CAP WAS NOT SECURE ON THE NEWLY PLACED EXTENSION TUBING SET. CAP TIGHTENED AND LEAKING STOPPED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22345231 ↗