ICU Medical A1141Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00887709069343), received between Mar 25, 2024 and Jun 19, 2026 — classified as 1 death, 32 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 reports).

188 other recalls cover devices cleared under the same FDA submission (K964435); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Disconnection

  AN EVENT WAS REPORTED INVOLVING 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK WAS REPORTED THAT THE PATIENT HAS A PICC AND HAD A TRI-SET ATTACHED, WITH RUNNING LINES THROUGH TWO OF THE PORTS. ONE WAS CLAMPED AND CAPPED. GREEN PORT WAS FOUND IN THE PATIENT'S BED, HAD COME APART FROM THE TRI-SET. IT WAS REPORTED THAT, EVENT OCCURRED THAT REACHED THE PATIENT BUT WAS NOT FOLLOWED BY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566310 ↗
• MalfunctionMar 16, 2026Fluid/Blood Leak

  AN EVENT INVOLVING A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK REPORTED THAT INTRAVENOUS (IV) FLUID LEAKING FROM CRACKED QUAD SET. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603190 ↗
• MalfunctionFeb 10, 2026Crack

  AN EVENT INVOLVING A SMALLBORE TRIFUSE EXT SET WITH 3 MICROCLAVE REPORTED THAT THE REGISTERED NURSE (RN) WAS ATTEMPTING TO ATTACH SYRINGE TO INTRAVENOUS (IV) TUBING TO FLUSH THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WHEN THE IV TUBING CRACKED. LATER, THE RN CLAMPED PICC IN 2 PLACES AND DISCONNECTED CRACKED IV TUBING FROM THE LUMEN OF THE PICC. RN CHECKED PATENCY OF PICC LUMEN BY FLUSHING AND DRAWING BACK TO CHECK BLOOD RETURN. THE MEDICATIONS NEED TO BE RESTARTED UPON RECEIVING FROM PHARMACY. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301799 ↗
• DeathFeb 4, 2026Air/Gas in Device

  THE EVENT INVOLVED A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK. THE REPORT STATED THAT CODE EVENT IN 1900, WITH RETURN OF SPONTANEOUS CIRCULATION (ROSC) ACHIEVED AFTER APPROXIMATELY 15. FOLLOWING RESUSCITATION, AIR BUBBLES WERE NOTED IN THE IV TRI-SET DISTAL TO THE RED PORT WHERE CODE MEDICATIONS HAD BEEN ADMINISTERED. A HEAD ULTRASOUND REVEALED PNEUMOCEPHALUS, AND TELEMETRY REVIEW WAS SUSPICIOUS FOR A CORONARY EVENT. THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) DRESSING WAS TAKEN DOWN, AND THE ENTIRE LINE SETUP WAS CHANGED. NOTABLY, A CAP AND LINE CHANGE HAD BEEN PERFORMED APPROXIMATELY 50 MINUTES PRIOR TO THE ARREST. THE PATIENT PASSED AWAY AFTER THE EVENT. IT WAS UNCLEAR IF ANY INTERVENTIONS WERE DUE TO THE EVENT, AND THE ISSUE CURRENTLY REMAINS UNDER INVESTIGATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. NOTE: THE SPECIFIC DATE OF DEATH IS UNKNOWN BUT IT OCCURRED ON OR AFTER (B)(6) 2026.

  Patient problems: Air Embolism; Cardiac Arrest; Pneumocephalus

  MAUDE report 24258186 ↗
• MalfunctionNov 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING 9.5-INCH SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE CLEAR, NANOCLAVE (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK WHERE IT WAS STATED THAT "A LARGE WET SPOT WAS FOUND UNDER THE QUAD SET. THE NEONATAL NURSE PRACTITIONER (NNP) ORDERED TO RESTRING TOTAL PARENTERAL NUTRITION (TPN) AND CHECK A GLUCOSE LEVEL. WHEN DISCONNECTED AND FLUSHED THROUGH THE RED PORT WAS FOUND TO BE LEAKING." THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23455157 ↗
• MalfunctionOct 28, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE COMPLAINT INVOLVED THE FOLLOWING DEVICE: 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK. THE BLOOD PORT OF THE DEVICE REPORTEDLY BROKE WHILE ATTEMPTING TO FLUSH FOR A PATIENT. THE RN WENT TO THE PATIENT ROOM TO ADMINISTER MEDICATION OF IV ZOFRAN. THE RN TOOK OFF THE GREEN HUB CAP OFF OF THE BLOOD PORT, CLEANED PER POLICY WITH PREVANTIX, AND ATTACHED A SALINE FLUSH. AS THE FLUSH WAS ATTACHED, A LOUD POPPING SOUND WAS HEARD WITH SMALL PLASTIC FRAGMENTS AND IV FLUIDS SPILLING ONTO BED. THE PIV (PERIPHERAL VENOUS LINE) BEGAN TO "BACKFLOW BLOOD TOWARDS NO OPEN SITE OF TUBING". THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407995 ↗
• MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT WAS REPORTED VIA A MEDWATCH REPORT # (B)(4) (ATTACHED). THE REPORT STATED "SINGLE LUMEN PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] WAS INFUSING AMPICILLIN. TECH CALLED RN TO BEDSIDE FOR BLOOD COMING OUT OF PICC. NURSE PAUSED FLUIDS AND CHECKED LINE. TRIFUSE EXTENSION APPEARED TO HAVE A LEAK. BLOOD HAD BACK UP AND WAS LEAKING OUT OF TRIFUSE EXTENSION. MANUFACTURER RESPONSE FOR EXTENSION SET, 9.5¿ 1.4 SMALLBORE TRIFUSE SET, 3 MICROCLAVE CLEAR, NANOCLAVE, 3 CHECK VALVES (PER SITE REPORTER). YES, THEY WERE MADE AWARE ON [DATE REDACTED]. CURRENTLY AWAITING MANUFACTURER RESPONSE." ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THE REPORT WAS COMPLETED BY (B)(6) A RISK MANAGER OF (B)(6) HOSPITAL. THE DATE OF THIS REPORT WAS ON JUL-2025. THIS IS A PRODUCT PROBLEM WITH THE EVENT DATE JUN-2025. THE OUTCOME ATTRIBUTED TO ADVERSE EVENT OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS. THE AGE OF THE PATIENT IS 13 DAYS OLD. THE SUSPECTED DEVICE IS A 9.5" (24 CM) SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK WITH LIST NUMBER A1141 AND UNKNOWN LOT NUMBER WITH PROCODE FMG, COMMON DEVICE NAME. THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22947938 ↗
• MalfunctionAug 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REAGARDING A 9.5" (24 CM) SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK WHERE IT WAS REPORTED MULTIPLE COMPLAINTS OF LEAKING NOTED ON WHITE MICROCLAVE LUMEN WHEN INFUSING LIPIDS. THERE EVENT OCCURRED DURING PATIENT INFUSION; HOWEVER, HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710132 ↗
• MalfunctionJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK WHERE IT WAS REPORTED WHEN FLUSHING ABOVE THE RED PORT IV FLUID WAS COMING OUT OF THE RED PORT. PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WAS PATENT AND WAS STATED TO BE A TRI-SET ISSUE. THERE WERE NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372189 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN UNSPECIFIED TRISET GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT THEY HAVE MULTIPLE REPORTS OF LEAKING TRISET. THE REPORTER STATED THAT THE TRI-SET LEAKING UPON STARTING TOTAL PARENTAL NUTRITION (TPN) AND LIPIDS OUT OF THE RED MEDPORT. THE DISPOSABLE DEVICE WAS SAVED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735737 ↗
• MalfunctionFeb 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED AN UNSPECIFIED 9.4 IN APPX 1.4ML, SMALLBORE TRIFUSE SET, 3 MICROCLAVE CLEAR, NANOCLAVE, 3 CHECK VALVES THAT EXPERIENCED LEAKAGE DURING USE. THE REPORTER STATED THAT DURING FIRST CARE, THEY NOTICED THE PICC LINE WAS LEAKING TPN AND LIPIDS FROM THE MED PORT INTO THE PATIENT'S BED. THE CATHETER NEAR THE INSERTION SITE WAS FOUND CLAMPED FROM THE PREVIOUS SHIFT. AFTER PAUSING FLUIDS AND UNCLAMPING, THE CLINICIAN FLUSHED THE SITE AND RESTARTED THE TPN AND LIPIDS. THEN THEY NOTICED THEY WERE STILL LEAKING OUT OF THE MED PORT AND CALLED TO UPDATE THE NNP./NEONATAL NURSE PRACTICIONER IT WAS ALSO STATED THAT PATIENT'S HARM HAS POTENTIAL FOR CLABSI/ CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION. THE ORIGINAL PROCEDURE INTENDED WAS UNKNOWN. THE PATIENT INVOLVED WAS REPORTED TO BE "0.02 OLD AND FEMALE." CLARIFICATION IS BEING REQUESTED. THE DEVICE WAS NOT REPROCESSED AND REUSED ON A PATIENT. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341140 ↗
• MalfunctionDec 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK WHERE THE CUSTOMER REPORTED THAT THE DEVICE LEAKED AFTER HOURS OF USE WHILE ATTACHED TO A PATIENT. THERE WAS NO WAY TO KNOW IT WAS DEFECTIVE UNTIL IT LEAKED. THERE WERE NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS PATIENT INVOLVEMENT, UNKNOWN DELAY IN THERAPY; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048032 ↗
• MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK. THE REPORTER STATED THAT THE LINE WAS CHANGED AT AROUND 1700 AND THEN THEY NOTICED AN IV SET TRISET WAS FOUND TPN LEAKING IN BED AROUND 1800 BY APN (ADVANCED PRACTICE NURSE). THEN THE RN (REGISTERED NURSE) WAS FEEDING ANOTHER BABY AND LINE WAS CHANGE WITH NEW TRISET AT 1900. THE ORIGINAL INTENDED PROCEDURE WAS UNKNOWN. THERE WERE NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS PATIENT INVOLVEMENT, HOWEVER, HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21040290 ↗
• MalfunctionDec 30, 2024Separation Problem; Separation Problem

  THE EVENT INVOLVED A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK. THE CUSTOMER REPORTED THAT THE PATIENT HAD 2 THREE WAY EXTENSION PIECES ATTACHED TO A BROVIAC. THERE WERE CULTURES ORDERED AT 1600. WHEN THEY WENT TO DRAW BLOOD FOR THE CULTURE, THE HUB WHERE THEY DRAW CULTURES FROM WITH ONE OF THE 3 WAY EXTENSIONS, CAME OFF. THEY IMMEDIATELY PRIMED A SIX WAY EXTENSION PIECE, SCRUBBED ONE LUMEN AT A TIME AND ADDED CONTINUOUS MEDICATIONS TO SIX WAY LUMEN. DRUGS INFUSING THROUGH LINE WERE FENTANYL, VERSED, VECURONIUM, PRECEDEX, AND 0.9 @ 5 ML/HR. EPINEPHRINE WAS OFF BUT Y'D IN AND NEEDED TO BE RESTARTED WITHIN 15 MINUTES AFTER THIS EVENT TOOK PLACE. THERE WERE NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS PATIENT INVOLVEMENT; HARM WAS NO REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039913 ↗
• MalfunctionDec 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK WHERE IT WAS REPORTED LEAKAGE AT THE BONDED CAP ON THE WHITE LUMEN OF THE INTRAVENOUS (IV) TRISET, WHICH RESULTED IN THE NEED FOR THE PATIENT¿S TOTAL PARENTERAL NUTRITION / LIPIDS (TPN/IL) TO BE DISCARDED PREMATURELY. UPON ASSESSMENT, IT WAS FOUND THAT LIPIDS WERE LEAKING FROM THE BONDED CLAVE PIECE (WHITE) OF THE TRISET. THE EVENT OCCURRED DURING PATIENT CARE IN THE C4C UNIT. IT WAS NOTED THAT THE DEVICE HAD NOT BEEN REPROCESSED OR REUSED. THE PATIENT INVOLVED WAS A 4-WEEK-OLD FEMALE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20883126 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  THE EVENT INVOLVED A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK WHERE IT WAS REPORTED THAT THE BLOOD PORT OF IV TRI SET TUBING WAS LEAKING/DRIPPING. IT WAS ALSO NOTED THAT IT WAS NOT ALLOWING FLUIDS TO GET ALL THE WAY THROUGH LINE. ADDITIONALLY, THE PORT FLUSHED AND DREW BACK BUT WOULD LEAK WHEN MEDICATION WAS RUNNING. THE EVENT WAS NOTED DURING PATIENT CARE. THE PATIENT WAS A 1-YEAR-OLD MALE. THE AFFECTED AREA IS H4A. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863121 ↗
• MalfunctionNov 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK. IT WAS REPORTED THAT THE TRISET WAS LEAKING AT THE BONDED CLAVE SITE DURING AN INFUSION OF LIPIDS ON A PATIENT IN THE FACILITY'S UNIT H8A. THERE WAS NO REPORT OF HUMAN HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784472 ↗
• MalfunctionOct 16, 2024Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT A SMALLBORE TRIFUSE SET, 3 MICROCLAVE CLEAR WAS FOUND TO BREAK AND CAUSE A LEAK DURING PATIENT USE. THE REPORT STATED, "QUADSET SNAPPED OFF OF PIV WHILE DRAWING LABS, CAUSING BLOOD TO FLOW ON TO PATIENT/BED." THE PACKAGING WAS NOT SAVED. THIS IS A SINGLE-USE DEVICE THAT WAS NOT REPROCESSED NOR REUSED ON A PATIENT. SAMPLE PHOTOS ARE PROVIDED SHOWING THE DEFECTIVE DEVICE. THE DEVICE INVOLVED IN THIS EVENT IS NOT AVAILABLE IN THE FACILITY. NO OTHER DEVICES WERE BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467776 ↗
• MalfunctionOct 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK GENERATED A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT TRISET ON IJ LEAKING FROM THE TEAL LUMEN. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464938 ↗
• MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK GENERATED A LEAK DURING PATIENT USE IN LOCATION H12. IT WAS REPORTED THAT THE INTRAVENOUS (IV) TUBING WAS LEAKING NEAR THE BIFURCATION OF THE TRISET. A SIMPLE PICTURE HAS BEEN PROVIDED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20454562 ↗
• MalfunctionSep 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK. THE REPORTER STATED THAT UPON IV ASSESSMENT DURING CARE, THIS RN NOTICED A WET SPOT ON THE BED. THE RN FOUND LEAKAGE POINT ON THE QUAD SET ON THE YELLOW PORT. THE LEAKING QUAD SET WAS REMOVED AND REPLACED WITH NEW QUAD SET. IT WAS UNKNOWN IF SOMEONE DIRECTLY OPERATING THE DEVICE AT THE TIME OF THE EVENT. THERE WAS PATIENT INVOLVEMENT AGE 4 DAYS OLD, AND GENDER IS FEMALE AND UNKNOWN ADVERSE EVENT. THE MEDICATION INVOLVED WAS TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301542 ↗
• MalfunctionAug 10, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK WAS FOUND TO HAVE UNCONTROLLED FLOW DURING USE ON A PATIENT. THE REPORT STATED THAT THEY WERE OBTAINING LABS USING THE SINGLE STOPCOCK METHOD. WHEN RETURNING BLOOD, BLOOD BYPASSED THE TRI-SET CLAMP AND INFILTRATED INTO INFUSING TUBING AND LINES. THE SAMPLE WAS NOT REPROCESSED AND REUSED, AND IT IS AVAILABLE FOR INVESTIGATION. A SAMPLE PHOTO WAS PROVIDED SHOWING THE AFFECTED PRODUCT. THERE WAS A DELAY IN THERAPY DUE TO TRI SETS NEEDING TO BE CHANGED OUT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19957775 ↗
• MalfunctionAug 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK. IT WAS REPORTED THAT THE TRI-SET LEAKING AT BONDED SITE. IT WAS UNKNOWN IF SOMEONE WAS DIRECTLY OPERATING THE DEVICE AT THE TIME OF EVENT. IT WAS UNKNOWN IF THERE WERE OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE EVENT OCCURRED DURING INFUSION WITH MEDICATION INVOLVE FENTANYL. THERE WAS A DELAY IN THERAPY DUE TO TRI SETS NEEDED CHANGED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19946386 ↗
• MalfunctionAug 7, 2024Fluid/Blood Leak; Infusion or Flow Problem; Fluid/Blood Leak; Infusion or Flow Problem

  THE EVENT INVOLVED A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK WHERE THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO GET THE BLOOD PORT TO CLEAR WHEN FLUSHING THE TRISET. THE CUSTOMER TRIED TO FLUSH FROM ONE OF THE OTHER LUMENS AND THEY DID; SALINE SQUIRTED OUT OF THE BLOOD PORT. THE DEVICE WAS NOT REPROCESSED OR REUSED. THE CUSTOMER STATED THAT THERE WAS A DELAY IN THERAPY DUE TO TRI SETS NEEDING CHANGED OUT. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933874 ↗
• MalfunctionAug 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK GENERATED A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE TRIFUSE SET LEAKED ON THE YELLOW PORT WHERE MICROCLAVE IS BONDED. THE PACKAGING WAS NOT SAVED. THE DEVICE WILL BE RETURNED VIA THE MANUFACTURER¿S PREFERRED RETURN PROCESS. THE DEVICE INVOLVED IN THIS EVENT IS NOT AVAILABLE IN THE FACILITY. UNKNOWN OTHER DEVICES WERE BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19903903 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964435. One submission often covers many models, so check the product and lot details in each record.

• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-0154-2026 · Oct 2, 2025 · Open, Classified
  IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B
• Z-1721-2022 · Aug 1, 2022 · Open, Classified
  6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
• Z-0956-2021 · Dec 2, 2020 · Terminated
  60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl
• Z-0958-2021 · Dec 2, 2020 · Terminated
  154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac
• Z-0955-2021 · Dec 2, 2020 · Terminated
  60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr
• Z-0957-2021 · Dec 2, 2020 · Terminated
  7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro
• Z-0202-2021 · Jul 6, 2020 · Terminated
  8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(
• Z-0199-2021 · Jul 6, 2020 · Terminated
  9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709069340(17)250101(30)50(10)455847
• Z-0233-2021 · Jul 6, 2020 · Terminated
  139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)1088
• Z-0186-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)
• Z-0227-2021 · Jul 6, 2020 · Terminated
  142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948
• Z-0194-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709065069(17)250101(30)50(10)4590843;(0
• Z-0226-2021 · Jul 6, 2020 · Terminated
  112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088518(17)241101(30)25(10)4475764 (01)108

…and 173 more.