Caresite MicroRecalls & reported problems across all models

We found 5 models of Caresite Micro by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Feb 18, 2025 and Sep 23, 2026 — classified as 3 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Caresite Micro problems

Caresite Micro models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Caresite Micro™ 354269

  Set, administration, intravascular
  20 reports
• Caresite Micro™ 415400

  Set, administration, intravascular
  11 reports
• Caresite Micro™ 354268

  Set, administration, intravascular
  5 reports
• Caresite Micro™ 354267

  Set, administration, intravascular
  3 reports
• Caresite Micro™ 354265

  Set, administration, intravascular
  1 report

Recent Caresite Micro adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionAug 25, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50431417 ↗
• MalfunctionAug 25, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50431410 ↗
• MalfunctionJun 2, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: IN THE NICU, "CLAVES" ARE USED AT THE END OF OUR TUBING DEVICES THAT ALLOW US TO ATTACH A LUER-LOCK SYRINGE TO FLUSH/ADMINISTER, ETC. THERE IS A NEW "CLEAR" CLAVE PRODUCT THAT IS BEING STOCKED ON THE FLOOR (THE PRIOR CLAVE WAS "GREEN). RN HAS NOTED ON MULTIPLE OCCASIONS WHERE THE PLUNGER INSIDE OF THE CLAVE (WHICH SEEMS TO BE SPRING OPERATED) HAS NOT SPRUNG BACK UP/HAS STAYED DOWN IN AN ENGAGED POSITION. TYPICALLY, WHEN ATTACHING A SYRINGE TO THE CLAVE, YOU HAVE TO PUSH IN AND TWIST, AND THE PUSH IN MECHANISM IS STUCK IN PLACE. THIS ENCOUNTER OF A MALFUNCTIONED CLAVE CAUSED A LARGE AIR BUBBLE TO BE IN MY MED-LINE ATTACHED TO THE CLAVE, THAT IS ATTACHED TO AN UMBILICAL CENTRAL LINE. RN WAS AWARE OF AIR BUBBLE AND INTERVENED BEFORE IT REACHED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361180 ↗
• MalfunctionMay 20, 2026Leak/Splash

  THIS COMPLAINT DOCUMENTS THE CLAIMANT'S ALLEGATION THAT IN SOME INSTANCES, THE SECURITY CAP FALLS OFF AFTER THE TUBING HAS BEEN CONNECTED TO THE PATIENT'S IV SET UP, EVEN IN THE ABSENCE OF ANY JARRING OR EXTERNAL DISRUPTION. CUSTOMER ALLEGES THAT THIS CREATES A SIGNIFICANTLY INCREASED RISK OF STERILE END OF THE TUBING TOUCHING A CONTAMINATED SURFACE WHEN SETTING UP OR RECONNECTING A PATIENT IV. IN ONE SUCH INCIDENT THE B. BRAUN EXTENSION TUBING CAP ON AN IV CATHETER DISCONNECTED DURING CHEMOTHERAPY INFUSION RESULTING IN A BACKFLOW OF BLOOD AND CHEMOTHERAPY INFUSION ONTO THE PATIENT.

  Patient problems: Chemical Exposure

  MAUDE report 25234584 ↗
• 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 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: SINCE CS MICRO ROLLED OUT, 2 CLABSI'S REPORTED IN THE NICU IN SEPTEMBER AND OCTOBER. HAVEN'T HAD ANY REPORTED CLABSI IN NICU IN 1500 DAYS.

  Patient problems: Bacterial Infection

  MAUDE report 23656244 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: SINCE CS MICRO ROLLED OUT, 2 CLABSI'S REPORTED IN THE NICU IN SEPTEMBER AND OCTOBER. HAVEN'T HAD ANY REPORTED CLABSI IN NICU IN 1500 DAYS.

  Patient problems: Bacterial Infection

  MAUDE report 23656243 ↗

Other B. Braun Medical Inc. products

• Infusomat54 models · 2,783 reports · 30 recalls
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• Perifix57 models · 224 reports · 20 recalls
• Extension Set41 models · 101 reports · 16 recalls
• Design Options116 models · 132 reports · 14 recalls
• Blood Administration Set24 models · 177 reports · 13 recalls