ICU Medical MC33038Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00887709037281), received between Oct 17, 2024 and Jul 24, 2025 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (24 reports).

8 other recalls cover devices cleared under the same FDA submission (K100576); 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE IN JUNE, A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING GENERATED A LEAK DURING PATIENT USE. THE REPORT STATED THAT THE INTRAVENOUS (IV) WAS PATENT, AND WHEN THEY WENT TO FLUSH THE LINE, THERE WAS A NOTABLE LEAK AT THE SITE OF THE TUBING MEETING THE NEEDLELESS END CAP. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587040 ↗
• MalfunctionJul 17, 2025Break; Break

  A COMPLAINT WAS RECEIVED REGARDING A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DTEHP TUBING THAT EXPERIENCED BREAKAGE AT THE LUER. THE REPORTER CONFIRMING THAT THE PRODUCT HAD ISSUES. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT. UPDATE: (20-JUN-2025) THE ISSUE WAS DEFECTIVE/BROKEN AROUND FEMALE LUER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538120 ↗
• MalfunctionMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING. LEAKING WAS REPORTED WHEN USING THE MICROCLAVE WHILE PUTTING IN AN IV AND ATTACHING THE DEVICE AND THEN PRIMING/FLUSHING NORMAL SALINE. THE PATIENT WAS RECEIVING DOCETAXEL AND HAD DRIPS ON ARM AT CONNECTIONS, THEY USED SOAP AND WATER TO WASH. THEIR USUAL SET UP WAS WITH AN UNSPECIFIED ANGI CATH AND THIS J LOOP CONNECTED TO NON-PVC ALARIS TUBING. THERE WAS ALSO SLIGHT DELAY AS THE NURSE DONNED PPE, SWITCHED OUT JLOOP AND THEN ADMINISTERED REST OF INFUSION. IT WAS STATED THAT THEY COULD NOT FIGURE OUT IF THERE MAY BE A "CRACK" ON THE DEVICE OR JUST PART OF THE PLASTIC THAT IS SUPPOSED TO BE THERE. THERE WAS NO HARM AS A RESULT OF THE COMPLAINT ISSUE.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996194 ↗
• MalfunctionMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING. LEAKING WAS REPORTED WHEN USING THE MICROCLAVE WHILE PUTTING IN AN IV AND ATTACHING THE DEVICE. BLOOD CAME BACK IN ONE INSTANCE AND ONE WAS FLUSHING SALINE. THE PATIENT WAS RECEIVING DOCETAXEL AND HAD DRIPS ON ARM AT CONNECTIONS, THEY USED SOAP AND WATER TO WASH. THEIR USUAL SET UP WAS WITH AN UNSPECIFIED ANGI CATH AND THIS J LOOP CONNECTED TO NON-PVC ALARIS TUBING. THERE WAS ALSO SLIGHT DELAY AS THE NURSE DONNED PPE, SWITCHED OUT JLOOP AND THEN ADMINISTERED REST OF INFUSION. IT WAS STATED THAT THEY COULD NOT FIGURE OUT IF THERE MAY BE A "CRACK" ON THE DEVICE OR JUST PART OF THE PLASTIC THAT IS SUPPOSE TO BE THERE. THERE WAS NO HARM AS A RESULT OF THE COMPLAINT ISSUE.

  Patient problems: Chemical Exposure

  MAUDE report 21994538 ↗
• MalfunctionMay 6, 2025Crack; Crack

  THE EVENT WAS REPORTED VIA MEDWATCH MDR REPORT #: MW5168266 AND THE PRODUCT INVOLVED WAS A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING. THE REPORT STATED "INTRAVENOUS PLACED AND EXTENSION LOOP ATTACHED TO PATIENT. UPON ATTEMPTING TO FLUSH BLOOD NOTED TO BE DRAINING OUT OF LOOP HUB. LOOP REMOVED AND NEW APPLIED. HUB OF EXTENSION LOOP VISIBLY CRACKED UPON EXAMINATION AFTER REMOVING FROM PATIENT." THE INITIAL REPORTER WAS A RISK MANAGER AND ASKED TO REMAIN CONFIDENTIAL. THERE WAS PATIENT INVOLVEMENT, UNKNOWN DELAY IN THERAPY; THERE WAS NO REPORT OF HARM AS A CONSEQUENCE OF THIS EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971431 ↗
• MalfunctionMay 6, 2025Break; Crack; Break; Crack

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" (18 CM) APPX 0.41 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE¿ CLEAR, PURPLE CLAMP, LUER LOCK WHERE THE CUSTOMER REPORTED THAT THE DEVICE WAS DEFECTIVE/BROKEN AT THE FEMALE LUER. THE INCIDENT OCCURRED 2 TIMES. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970823 ↗
• MalfunctionApr 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON VARIOUS DATES IN (B)(6) 2025 INVOLVING A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING. THE CUSTOMER REPORTED LEAKING J-LOOPS FOR IV EXTENSIONS, IT HAS HAPPENED 5X IN THE LAST TWO WEEKS. THE PATIENT IS A 64-YEAR-OLD FEMALE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21743313 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING THAT EXPERENCED LEAKAGE. REPORT 1 OF 2. MEDWATCH REPORT #MW5166363 AND MW5166364 RECEIVED ON 03-MAR-2025 STATED THAT WHEN CHANGED PIV (PERIPHERAL INTRAVENOUS LINE), J-LOOP FLUSHED WITHOUT ISSUE. PUT DRESSING ON SITE WAS CLEAN DRY AND INTACT. NOTED PINK DRAINAGE ON ONE SIDE OF DRESSING, FLUSHED AGAIN AND NOTED SCANT DRAINAGE UNDER DRESSING. TOOK DRESSING OFF, NOTED J-LOOP SECURE TO IV CATHETER, UNABLE TO SEE WHERE LEAKING WAS FROM. CHANGED J-LOOP, INITIAL FLUSH PRIOR TO ATTACHING TO PATIENT, NO LEAK NOTED. ATTACHED TO CATHETER, NOTED SCANT LEAK. CHANGED J-LOOP AGAIN WITHOUT CONTINUED LEAKING. BOTH (J-LOOPS) WHICH LEAKED ARE FROM ICU MEDICAL. ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THE REPORT WAS COMPLETED BY A RISK MANAGER. INITIAL REPORTER ASKED TO REMAIN CONFIDENTIAL. THE DATE OF THIS REPORT WAS ON 12-FEB-2025 AND THE DATE OF EVENT WAS ON (B)(6) 2025. THE PATIENT INVOLVED IS A 43YR OLD MALE NON-HISPANIC WHITE. THE SUSPECT MEDICAL DEVICE IS 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733432 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING THAT EXPERENCED LEAKAGE. REPORT 2 OF 2. MEDWATCH REPORT #MW5166363 AND MW5166364 RECEIVED ON 03-MAR-2025 STATED THAT WHEN CHANGED PIV (PERIPHERAL INTRAVENOUS LINE), J-LOOP FLUSHED WITHOUT ISSUE. PUT DRESSING ON SITE WAS CLEAN DRY AND INTACT. NOTED PINK DRAINAGE ON ONE SIDE OF DRESSING, FLUSHED AGAIN AND NOTED SCANT DRAINAGE UNDER DRESSING. TOOK DRESSING OFF, NOTED J-LOOP SECURE TO IV CATHETER, UNABLE TO SEE WHERE LEAKING WAS FROM. CHANGED J-LOOP, INITIAL FLUSH PRIOR TO ATTACHING TO PATIENT, NO LEAK NOTED. ATTACHED TO CATHETER, NOTED SCANT LEAK. CHANGED J-LOOP AGAIN WITHOUT CONTINUED LEAKING. BOTH (J-LOOPS) WHICH LEAKED ARE FROM ICU MEDICAL. ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THE REPORT WAS COMPLETED BY A RISK MANAGER. INITIAL REPORTER ASKED TO REMAIN CONFIDENTIAL. THE DATE OF THIS REPORT WAS ON 12-FEB-2025 AND THE DATE OF EVENT WAS ON 11-FEB-2025. THE PATIENT INVOLVED IS A 43YR OLD MALE NON-HISPANIC WHITE. THE SUSPECT MEDICAL DEVICE IS 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733416 ↗
• MalfunctionMar 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING THAT EXPERIENCED LEAKAGE. IT WAS STATED IN THE REPORT THAT WHEN FLUSHING, SALINE WAS POURING OUT CONNECTORS. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY.

  Patient problems: Insufficient Information

  MAUDE report 21668663 ↗
• MalfunctionMar 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING THAT EXPERIENCE LEAKAGE. IT WAS STATED IN THE REPORT THAT WHEN FLUSHING, SALINE WAS POURING OUT CONNECTORS. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668174 ↗
• MalfunctionMar 13, 2025Crack; Crack

  A MEDSUN MEDWATCH MANDATORY AND VOLUNTARY REPORT WITH MDR REPORT#: MW5165444 THAT STATED: ¿JLOOP FOR IV IS CRACKED.¿ THE INITIAL REPORTER WANTED TO REMAIN CONFIDENTIAL. THE SUSPECTED MEDICAL DEVICE WAS A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596603 ↗
• MalfunctionMar 13, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORT# MW5165441) THAT STATED: "WHEN GETTING SUPPLIES READY FOR IV INSERT, THE EXTENSION SET LOT 14121331, REF MC33038 HAD A LEAK/BREAK IN HUB AND/OR ATTACHMENT TO HUB." ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THE SUSPECTED MEDICAL DEVICE WAS A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING THE INITIAL REPORTER IS UNKNOWN AND IS A RISK MANAGER. INITIAL REPORTER ASKED TO REMAIN CONFIDENTIAL. NOTE: THE LEAKAGE WAS AN UNSPECIFIED AND UNKNOWN FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595711 ↗
• MalfunctionMar 11, 2025Leak/Splash; Leak/Splash

  A USER FACILITY MANDATORY MEDWATCH REPORT MW5165405 WAS RECEIVED THAT STATED, 'WHEN INSERTING AN IV, THE J LOOP WAS FOUND TO HAVE A CRACK AND WHEN FLUSHED IT SPRAYED AN UNSPECIFIED FLUID ALL OVER THE PATIENT AND THE ROOM'. THE OUTCOMES ATTRIBUTED TO AN UNSPECIFIED ADVERSE EVENT REQUIRED UNSPECIFIED INTERVENTION. THE INITIAL REPORTER IS A RISK MANAGER AND ASKED TO REMAIN CONFIDENTIAL. THE SUSPECT MEDICAL DEVICE IS A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING. THERE WAS NO REPORT OF HUMAN HARM OR DELAY IN THERAPY ASSOCIATED WITH THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21579571 ↗
• MalfunctionMar 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MULTIPLE 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING WITH VARIOUS EVENT DATES PROVIDED WERE REPORTED TO HAVE EXPERIENCED A SPRAY OF FLUIDS OF MEDICATION INTO THE CLINICIANS' FACES. THE REPORTER STATED THAT WHEN USING THE PURPLE CLAMP LUER LOCK FOR INJECTING OR FLUSHING PATIENT IVS, THEY FREQUENTLY ENCOUNTER SPRAY BACK INTO THEIR FACES. THIS SPRAY MAY CONTAIN BLOOD, SALINE, OR RADIOACTIVE ISOTOPES. THIS ISSUE OCCURS IN APPROXIMATELY ONE OUT OF EVERY TWENTY PATIENTS, MAKING IT A FAIRLY COMMON OCCURRENCE GIVEN THE DEPARTMENT'S PATIENT VOLUME. THIS SITUATION PRESENTS A SUBSTANTIAL RISK OF EXPOSURE TO BLOOD-BORNE PATHOGENS FOR THE STAFF. FURTHERMORE, THE INADEQUATE CONTAINMENT OF RADIOACTIVE ISOTOPES NECESSITATES EXTENSIVE INCIDENT RESOLUTION EFFORTS, OFTEN REQUIRING THE ASSISTANCE OF THE UNIVERSITY OF PITTSBURGH RADIATION SAFETY TEAM. THERE WERE REPORTED DELAYS IN COMPUTED TOMOGRAPHY (CT)/MAGNETIC RESONANCE IMAGING (MRI)/POSITRON EMISSION TOMOGRAPHY (PET) EXAMS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21567499 ↗
• MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE. A MEDWATCH REPORT MW5164173 WAS RECEIVED ON 17JAN2025 STATING THE FOLLOWING: INTRA VENOUS PLACED, BLOOD PULLING FROM J-LOOP ONTO PATIENT BED AND FLOOR. ADDITIONAL EVENT INFORMATION OBTAINED FROM THE MEDWATCH WAS AS FOLLOWS: THE INITIAL REPORTER IS UNKNOWN AND IS A RISK MANAGER. THE DATE OF THIS REPORT WAS ON 26-DEC-2024. THE SUSPECTED MEDICAL DEVICE WAS 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING. NO REDACTION NEEDED. THERE WAS UNKNOWN ADVERSE EVENT BUT NO REPORT OF ANY HUMAN HARM AS A RESULT OF THE COMPLAINT/EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21381103 ↗
• MalfunctionFeb 12, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING WHERE THE CUSTOMER REPORTED THAT THEY HAD NUMEROUS INSTANCES OF THE J-LOOPS FOR IV'S BEING "CRACKED" OR "LEAKING" NEAR THE CAP WHEN HOOKING THEM TO THE IV CATHETER, CAUSING THE PATIENT(S) TO BLEED UNTIL DISCONNECTED FROM THE IV CATHETER. THERE WAS PATIENT INVOLVEMENT, BUT NEITHER HARM NOR MEDICAL INTERVENTION WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366463 ↗
• MalfunctionFeb 10, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED AN EXTENSION SET 7 SMALLBORE PRESSURE INFUSION (10 ML) WITH UNKNOWN PRODUCT CODE AND LOT NUMBER. THE EVENT WAS REPORTED VIA MEDWATCH UF/IMPORTER REPORT# MW5163771 WITH MDR REPORT KEY: (B)(4) ON (B)(6)2025, WHICH STATED: "WHEN ATTEMPTING TO FLUSH IV RN NOTICED THAT THERE WAS SALINE COMING FROM THE HUB OF THE T CONNECTOR. RN CHANGED OUT THE T CONNECTOR AND NO FURTHER ISSUES. UPON FURTHER INSPECTION THERE WAS SOME SORT OF CRACK UNDERNEATH THE CAP OF THE TUBING CAUSING THE LEAK.¿ THERE WAS PATIENT INVOLVEMENT, DELAY IN THERAPY, BUT HARM WAS NOT REPORTED AS CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21347774 ↗
• MalfunctionFeb 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING THAT EXPERIENCED LEAKAGE. THE REPORTER STATED THAT THEY ENCOUNTERED ANOTHER DEVICE THAT LEAKED AT THE CLAVE OUT OF THE PACKAGE (MC33038). THEY SWITCHED FOR ANOTHER CLAVE, BUT IT STILL LEAKED. BOTH CLAVES WERE SECURED TIGHTLY ON THIS CLEAN, DRY EXTENSION LOOP. THERE IS NO CRACK IN ANY OF THE DEVICES THAT THEY CAN SEE. THE EVENT DATE WAS UNKNOWN. SAMPLE PHOTOS WERE PROVIDED THAT SHOWED THE INVOLVED PRODUCTS INSIDE THE PACKAGING WITH THE PRODUCT'S INFORMATION. THE EVENT DATE WAS ON 11-JAN-2025 DURING PRIMING AFTER OPENING THE PACKAGE. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341162 ↗
• MalfunctionFeb 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING. LEAKAGE OF AN UNSPECIFIED FLUID WHERE J-LOOP CONNECTS TO THE INTRAVENOUS (IV) LINE WAS REPORTED. THERE WAS NO HUMAN HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341047 ↗
• MalfunctionFeb 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A TO 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG), EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING WHERE THE CUSTOMER REPORTED THAT THE PATIENT RANG CALL LIGHT AND STATED THAT HER IV SITE WAS LEAKING BLOOD. THE NURSE ENTERED THE ROOM AND REMOVED STERILE COVER; THE IV SITE WAS NOT LEAKING BUT IT WAS NOTED THAT THE BLOOD WAS COMING OUT OF THE TOP PART OF THE J-LOOP. THE NURSE CHECKED TO MAKE SURE THAT THE J-LOOP WAS TIGHTENED ALL THE WAY, AND IT WAS. THE J-LOOP WAS REPLACED, THE AREA WAS CLEANED AND DRESSING WAS REPLACED. THE EVENT OCCURRED IN THE EMERGENCY DEPARTMENT DURING PATIENT USE; THE PRODUCT WAS IN CONTACT WITH BODILY FLUIDS AND WAS NOT IN CONTACT WITH A HAZARDOUS AGENT. 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 21340467 ↗
• MalfunctionFeb 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING WHERE THE CUSTOMER REPORTED LEAKING AT PORT SITE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT BUT THE CUSTOMER STATED THAT THE PRODUCT WAS IN CONTACT WITH BODILY FLUIDS BUT WAS NOT IN CONTACT WITH A HAZARDOUS AGENT. HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340462 ↗
• MalfunctionJan 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING WHERE IT WAS REPORTED THAT IV WAS PLACED, J-LOOP ATTACHED, BLOOD STARTED DRIPPING/POOLING OUT OF ATTACHABLE SCREWED END. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS USE ON PATIENT DURING BLOOD DRAW. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200862 ↗
• MalfunctionJan 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING. THE COMPLAINT REPORT STATED THAT AT THE J-LOOP (ATTACHED TO IV CATHETER), BLOOD CAME OUT OF THE TUBING FROM THE BLUE PART (AT THE CONNECTION SITE THAT ATTACHES TO THE END), BECAUSE THE CONNECTION PIECE WAS CRACKED. THIS OCCURRED DURING A BLOOD DRAW AFTER CONNECTION WAS MADE, BLOOD POOLED ONTO THE FLOOR. THE STAFF SUBSEQUENTLY FLUSHED AND CLEANED OUT THE FAULTY J-LOOP. THE SAMPLE PHOTO WAS PROVIDED SHOWING THE J-LOOP WITH BLOOD AND WHEN IT WAS FLUSHED AND CLEANED OUT. THERE WAS NO PATIENT HARM OR ADVERSE EVENT AS A CONSEQUENCE OF THIS COMPLAINT/EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21152345 ↗
• MalfunctionDec 30, 2024Disconnection; Fluid/Blood Leak; Material Twisted/Bent; Disconnection; Fluid/Blood Leak; Material Twisted/Bent

  THE EVENT INVOLVED A 7"(18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING WHERE IT WAS REPORTED PATIENT TO UNIT WITH NEW IV, LEAKING, CAME UNHOOKED AT HUB, AND WAS BENT WHEN DISCONTINUED. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21043234 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100576. One submission often covers many models, so check the product and lot details in each record.

• Z-3160-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-1720-2022 · Aug 1, 2022 · Open, Classified
  8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
• Z-0204-2021 · Jul 6, 2020 · Terminated
  6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per
• Z-0192-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 mul
• Z-0193-2021 · Jul 6, 2020 · Terminated
  6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouche
• Z-0201-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case.
• Z-0197-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multi
• Z-1916-2020 · Oct 4, 2019 · Terminated
  REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889