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Lifeshield 2066828Recalls & reported problems

ICU Medical, Inc. · LIFESHIELD, Extension Set - 17 Inch, 0.2 Micron Filter, CLAVE Y-Site, Secure Lock · Class 2

Quick summary

This ICU Medical Lifeshield extension set is an IV line with a 0.2 micron filter and a Clave Y-site, used to run IV fluids, nutrition and chemotherapy. Most of the 39 reports describe fluid or blood leaking from the filter or tubing, sometimes during hazardous drug infusions; a few mention air in the line, no flow, or cracks. Two injuries were reported and no deaths. No recalls name this device. Reports rose from 4 in the earlier 12 months to 14 in the most recent.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
38
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10887787005919), received between Jan 22, 2019 and Aug 27, 2026 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (31 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 3 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 4 reportsJan 2026: 1 reportsFeb 2026: 3 reportsMar 2026: 2 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fluid/Blood Leak31
  • Air/Gas in Device3
  • No Flow2
  • Adverse Event Without Identified Device or Use Problem1
  • Break1
  • Complete Blockage1
  • Crack1
  • Disconnection1

Patient problems

  • No Clinical Signs, Symptoms or Conditions22
  • Chemical Exposure12
  • No Consequences Or Impact To Patient11
  • Arrhythmia2
  • Hypersensitivity/Allergic reaction1
  • Hypoglycemia1
  • Insufficient Information1

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 27, 2026Fluid/Blood Leak

    A reported incident involving a Extension Set, 17 Inch, 0.2 Micron Filter, CLAVE(TM) Y-Site, Secure Lock. It was reported that an infant was receiving Total Parenteral Nutrition (TPN) through IV tubing when leakage was observed from the filter. The filter was connected to the administration set infusing the TPN solution. Upon identification of the leak, the filter was removed and replaced using sterile technique, and the TPN infusion was resumed. No blood or body fluids were present in the line. The event occurred during infusion and no injury or adverse event was reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50487078 ↗
  • MalfunctionApr 14, 2026Fluid/Blood Leak

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED AN EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK WHERE THE CUSTOMER REPORTED CONCERNS OF THE DEVICE LEAKING WHEN ADMINISTERING HAZARDOUS AEROSOLIZING MEDICATIONS. IMMEDIATE SOLUTION: 5A WILL USE 120493 - TUBING IV SET PLUM W/.22 MICRON H/P FILTER TO ALIGN WITH BEHRING PRACTICE FOR HAZARDOUS MEDICATIONS REQUIRING A FILTER. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24873981 ↗
  • MalfunctionMar 19, 2026Fluid/Blood Leak

    THE MICRON FILTERS IN A EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK REPORTEDLY LEAKED WHILE RUNNING AMIO. THE REPLACEMENT DEVICE ALSO STARTED TO LEAK ON THE FOLLOWING SHIFT, CAUSING FURTHER DYSRHYTHMIAS. THE PATIENT EXPERIENCED INCREASING PREMATURE VENTRICULAR CONTRACTIONS (PVCS) AND DYSRHYTHMIAS. THERE WAS NO FURTHER CLINICAL IMPACT REPORTED. THIS EMDR REFLECTS THE SECOND OF TWO OCCURRENCES.

    Patient problems: Arrhythmia

    MAUDE report 24639080 ↗
  • MalfunctionMar 19, 2026Fluid/Blood Leak

    THE MICRON FILTERS IN A EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK REPORTEDLY LEAKED WHILE RUNNING AMIO. THE DAY NURSE REPORTED THAT BED 17 WAS HAVING INCREASING PREMATURE VENTRICULAR CONTRACTIONS (PVCS), SO SHE CHECKED AND THEN OBSERVED THAT THE FILTER OF THE DEVICE WAS LEAKING DURING THE PATIENT'S INFUSION. THE PATIENT EXPERIENCED INCREASING PVCS AND DYSRHYTHMIAS. THERE WAS NO FURTHER CLINICAL IMPACT REPORTED. THIS EMDR REFLECTS THE FIRST OF TWO OCCURRENCES.

    Patient problems: Arrhythmia

    MAUDE report 24638735 ↗
  • MalfunctionFeb 26, 2026Fluid/Blood Leak

    (B)(4).

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

    MAUDE report 24457957 ↗
  • MalfunctionFeb 2, 2026Fluid/Blood Leak

    ADDITIONAL INFORMATION WAS RECEIVED: THERE WERE PATIENT INVOLVEMENT AND NO HARM. THERE WERE DELAY IN PATIENT TREATMENT FOR 2-3HOURS AND HAZARDOUS MEDICATION EXPOSURE TO STAFF. THERE WAS NO DELAY IN THERAPY THAT WAS CRITICAL TO THE PATIENT. INCREASED LENGTH OF STAY WAS THE EFFECT OF THE DELAY ON THE PATIENT. AEROSOLIZED PARTICLES COME IN CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER BUT NO NEGATIVE EFFECT. NEW TREATMENT MADE BY PHARMACY AND GIVEN TO PATIENT. PATIENT'S STATUS DID NOT CHANGE DUE TO THE EVENT. PATIENT STATUS WAS WITHIN NORMAL LIMITS AND THERE WAS NO CHANGE IN PATIENT STATUS DURING AND AFTER THE EVENT. THE SET UP WAS EXTENSION TUBING ADDED CLOSEST TO THE PATIENT. THE CHEMO SPILL CLEANED UP PER FACILITY PROTOCOL AND SPILL KIT WAS USED. IT IS UNKNOWN HOW LONG INTO THE INFUSION DID THE LEAK OCCURRED. PATIENT INVOLVED IS 46 Y/O MALE RECEIVING CONTINUOUS CHEMO INFUSION OF DOXORUBICIN (ADRIAMYCIN) 14 MG/M2 = 26 MG, ETOPOSIDE (VEPESID) 72 MG/M2 = 135 MG, VINCRISTINE (ONCOVIN) 0.4 MG/M2 = 0.8 MG IN NS 500 ML CHEMO INFUSION. THE SAMPLE WAS DISCARDED BUT CAN PROVIDE SISTER SAMPLE FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24242529 ↗
  • MalfunctionFeb 2, 2026Fluid/Blood Leak

    THE EVENTS OCCURRED ON TWO UNSPECIFIED DATES IN (B)(6) 2025. A USER FACILITY MANDATORY MEDWATCH REPORT NUMBER (B)(4) WAS RECEIVED WITH REGARDS TO AN EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK. IT WAS REPORTED THAT THE 0.2-MICRON FILTER WAS USED FOR A CONTINUOUS (UNSPECIFIED) CHEMOTHERAPY INFUSION, AND IT WAS DISCOVERED THAT THE INLINE FILTER WAS LEAKING CAUSING A CHEMO SPILL. THIS A SINGLE-USE DEVICE THAT WAS NOT REPROCESSED AND REUSED ON A PATIENT. THIS DEVICE WAS NOT EVER SERVICED BY A THIRD-PARTY SERVICER. THE EVENT OCCURRED IN PATIENT ROOM HOSPITAL. THE INVOLVED PATIENT WAS NOT HARMED. THIS OCCURRED ON 2 SEPARATE OCCASIONS 1 DAY APART. THIS REPORT REFLECTS THE FIRST OF THE TWO OCCURRENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24242477 ↗
  • InjuryJan 14, 2026Crack; Fluid/Blood Leak

    AN EMAIL WAS RECEIVED REGARDING AN EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK, STATING THAT THEY HAD A BABY THIS WEEK WITH A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE, AND THE NURSES NOTICED LEAKING IN VITRO FERTILIZATION (IVF) FROM THE INTRAVENOUS (IV) FILTER. WHEN THEY SWITCHED IT OUT, THEY NOTICED A CRACK IN THE FILTER. TOTAL PARENTERAL NUTRITION (TPN) IS BEING INFUSED AT 2.5 ML/HR. THE CRACKED FILTER RESULTED IN IV FLUID LEAKING, AND ULTIMATELY THE PICC LINE CLOTTED AND HAD TO BE REMOVED AND A NEW ONE WAS PLACED THE FOLLOWING DAY. A SAMPLE PHOTO WAS PROVIDED SHOWING THE PRODUCT INSIDE THE PACKAGING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24070041 ↗
  • MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED AN EXTENSION SET, 17INCH, 0.2 MICRON FILTER, CLAVE (TM), Y-SITE, SECURE LOCK AND IT WAS REPORTED THAT THE DEVICE HAS A LEAKING ISSUE DURING INFUSION OF MIXED CHEMOTHERAPY (DOXORUBICIN, ETOPOSIDE AND VINCRISTINE). THERE WAS PATIENT INVOLVEMENT, NO HARM AND DID CAUSE A DELAY IN THERAPY. THIS REPORT CAPTURES FIRST OF FOUR INCIDENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23835523 ↗
  • MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED AN EXTENSION SET, 17INCH, 0.2 MICRON FILTER, CLAVE (TM), Y-SITE, SECURE LOCK AND IT WAS REPORTED THAT THE DEVICE HAS A LEAKING ISSUE DURING INFUSION OF MIXED CHEMOTHERAPY (DOXORUBICIN, ETOPOSIDE AND VINCRISTINE). THERE WAS PATIENT INVOLVEMENT, NO HARM AND DID CAUSE A DELAY IN THERAPY. THIS REPORT CAPTURES THIRD OF FOUR INCIDENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23835522 ↗
  • MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED AN EXTENSION SET, 17INCH, 0.2 MICRON FILTER, CLAVE (TM), Y-SITE, SECURE LOCK AND IT WAS REPORTED THAT THE DEVICE HAS A LEAKING ISSUE DURING INFUSION OF MIXED CHEMOTHERAPY (DOXORUBICIN, ETOPOSIDE AND VINCRISTINE). THERE WAS PATIENT INVOLVEMENT, NO HARM AND DID CAUSE A DELAY IN THERAPY. THIS REPORT CAPTURES FOURTH OF FOUR INCIDENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23835519 ↗
  • MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED AN EXTENSION SET, 17INCH, 0.2 MICRON FILTER, CLAVE (TM), Y-SITE, SECURE LOCK AND IT WAS REPORTED THAT THE DEVICE HAS A LEAKING ISSUE DURING INFUSION OF MIXED CHEMOTHERAPY (DOXORUBICIN, ETOPOSIDE AND VINCRISTINE). THERE WAS PATIENT INVOLVEMENT, NO HARM AND DID CAUSE A DELAY IN THERAPY. THIS REPORT CAPTURES SECOND OF FOUR INCIDENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23835518 ↗
  • InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AN INCIDENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING THE EXT SET 17IN MACRO 0.2 M-FLTR CLV-Y SL REPORTED THAT THE PATIENT EXPERIENCING DAILY ALLERGIC REACTIONS AFTER BEGINNING PARENTERAL NUTRITION USING THIS INFUSION SET. WHICH RESOLVES WITH TREATMENT AND DOES NOT RETURN DESPITE CONTINUING THIS INFUSION. THERE WAS PATIENT INVOLVEMENT, AND PATIENT EXPERIENCED ALLERGIC REACTION AFTER INFUSION.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 23613486 ↗
  • MalfunctionOct 15, 2025No Flow; No Flow

    THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK WHERE IT WAS REPORTED THAT PATIENTS ARE NOT RECEIVING THEIR IV FLUID ADMINISTERED THROUGH MEDFUSION 4000IV PUMPS USING ICU MEDICAL TUBING. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING USE ON A PATIENT. PATIENTS ALL EXPERIENCED DECREASED URINE OUTPUT AND LOW BLOOD GLUCOSE LEVELS.

    Patient problems: Hypoglycemia

    MAUDE report 23283683 ↗
  • MalfunctionAug 22, 2025Complete Blockage; No Flow; Complete Blockage; No Flow

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED AN EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK. THE REPORTER STATED THAT, NEAR THE END OF A PATIENT'S INFUSION OF ENYZME SEBELIPASE, THE FILTER WAS CLOGGED AND THEY WERE UNABLE TO FLUSH OR ASPIRATE MEDICATION. THE FILTER/DEVICE WAS REMOVED FROM LINE AND THE REST OF INFUSION RESUMED (APPROXIMATELY 20 MLS). THERE WAS NO ADVERSE EVENT OR HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22877532 ↗
  • MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED AN EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK WHERE THE CUSTOMER REPORTED THAT THEY HAD 4 DEVICE LEAKING VANILLA TPN. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22064823 ↗
  • MalfunctionApr 30, 2025Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

    A COMPLAINT WAS RECEIVED REGARDING A LFIESHIELD¿ EXTENSION SET - 17 INCH 0.2 MICRON FILTER, CLAVE¿ Y-SITE, NON-DEHP THAT EXPERIENCED LEAKAGE AND AIR IN LINE. IT WAS REPORTED THAT THERE WAS A LEAKAGE FROM THE TUBING SPECIFICALLY THE TUBING PART OF THE FILTER WAS LEAKING TPN AND AIR WAS GETTING IN. ADDITIONALLY, THERE ARE ONE OR TWO PIN HOLES IN THE ACTUAL TUBING AND LEAKING THE FLUID THROUGH THE HOLES.

    Patient problems: Insufficient Information

    MAUDE report 21938644 ↗
  • MalfunctionSep 23, 2024Air/Gas in Device; Air/Gas in Device

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK. IT WAS STATED IN THE REPORT THAT THEY HAVE THREE INSTANCES WHERE AN INLINE IV FILTER HAS FILLED WITH AIR. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20285221 ↗
  • MalfunctionJun 21, 2024Break; Break

    I WAS REPORTED THERE WAS BREAKAGE AT THE CONNECTION OF AN EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. PER MEDWATCH: "REGISTERED NURSE (RN) WENT TO DISCONNECT PATIENTS LINE FOR LABS, AND WHEN RN TRIES TO UNTWIST THE BLUE CAP FROM THE PRIMARY TUBING, THE TIP OF THE FILTER SPUN OFF/BROKE OFF FROM THE COMPONENT AS A WHOLE BUT THE MIDDLE OF IT WAS STILL ATTACHED TO THE BLUE CAP. IF RN CONTINUED TO PULL IT APART, IT WOULD HAVE BROKEN AND STAYED STUCK INSIDE THE BLUE CAP. THE FILTER THAT WAS ATTACHED TO THE PRIMARY TUBING IS A TEMPORARY SUPPLY, DIFFERENT FROM OUR STOCK. RN ENDED UP REPLACING THE BLUE CAP AND LINES WITH OUR REGULAR CHEMO FILTER. THE ITEM LISTED IS THE DEFECTIVE/BROKEN PRODUCT, THE NURSE THEN USED OUR CHEMOTHERAPY FILTER PRODUCT AS A REPLACEMENT SINCE THE ABOVE PRODUCT WAS WHAT SHE FOUND DEFECTIVE. EXTENSION SET 17IN (0.2) MICRON FILTER, CLAVE Y SITE SECURE LOCK." PER MEDWATCH MANDATORY REPORT UF/IMPORTER # (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19581410 ↗
  • MalfunctionJun 20, 2024Material Separation; Material Separation

    THE PATIENT WAS BEING DE-ACCESSED FOR SEVEN-DAY PORT RE-ACCESS. REMOVED LINE FROM CAP. MALE END OF NEW FILTERS BEING USED BROKE OFF IN THE FEMALE END OF THE CAP. THE CAP HAD TO BE SWITCHED BEFORE DE-ACCESS COULD OCCUR. THE ISSUE COULD LEAD TO UNNECESSARY CAP CHANGES DUE TO FAULTY FILTERS. EXTENSION WITH FILTER ITEM BROKE APART. THE PATIENT INVOLVED WAS A 14-YEAR-OLD FEMALE. THE EVENT OCCURRED AT THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19575376 ↗
  • MalfunctionJun 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED A EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK WHERE IT WAS REPORTED IV EXTENSION SET WITH FILTER LEAKING AT THE FILTER SITE. PATIENT ON CYCLED TOTAL PARENTERAL NUTRITION (TPN) INFUSION HAD NEW BAG OF TPN PRIMED WITH IV EXTENSION SET 0.2-MICRON FILTER. WHEN TRACING THE LINE, THE REGISTERED NURSE (RN) FELT THAT THE FILTER WAS WET. THE TPN INFUSION WAS STARTED, AND RN NOTICED THE FILTER WAS LEAKING AT THE TOP. RN STOPPED THE INFUSION, REPLACED THE FILTER STERILELY AND RESTARTED IT. THERE WAS PATIENT INVOLVEMENT HOWEVER NO HARM AS A RESULT OF THE REPORTED ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19466256 ↗
  • MalfunctionJan 11, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

    THE EVENT INVOLVED A EXT SET 17IN MACRO 0.2 M-FLTR CLV-Y SL WHERE THE SECURE LOCK DISLODGED AT A CONNECTION POINT. BLOOD BACKED UP INTO THE TUBING AND AN UNSPECIFIED DRUG LEAKED ONTO THE FLOOR. THERE WAS A DELAY IN DISCHARGE AS TUBING WAS CHANGED. THE PATIENT AND FLOOR WERE CLEANED. THE FILTER CAME APART AT THE CONNECTION POINT WHERE THE TUBING CONNECTS TO THE FILTER. IT WAS A CLEAN BREAK AT THE TUBING. THE CONNECTION SIDE OF THE FILTER WITH THE SLIDE CLAMP. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT OR HUMAN HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18493952 ↗
  • MalfunctionSep 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING AN EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK WHERE IT WAS LEAKING OF AN UNSPECIFIED CHEMO DRUGS AT THE FILTER AND IT CAME IN CONTACT WITH THE PATIENT¿S HAND. THE CUSTOMER ALSO STATED THAT THEY COULD NOT SEE IF THE FILTER CRACKED, AND THIS HAPPENED NUMEROUS TIMES. THE ISSUE WAS NOTICED DURING INFUSION AT APPROXIMATELY 12 HOURS POST TO THE START OF INFUSION. WHEN ASKED IF THERE WAS MEDICAL INTERVENTION REQUIRED, IT WAS MENTIONED THAT THEY NEED TO GET A NEW BAG OF CHEMO WITH NEW TUBING AND RESTART THE INFUSION, SO THE INFUSION WAS PAUSED DURING THIS TIME. THERE WAS PATIENT INVOLVEMENT BUT NO REPORT OF HUMAN HARM. THIS IS THE SECOND OF TWO EVENTS.

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

    MAUDE report 15459818 ↗
  • MalfunctionSep 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING AN EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK WHERE IT WAS LEAKING OF AN UNSPECIFIED CHEMO DRUGS AT THE FILTER AND IT CAME IN CONTACT WITH THE PATIENT¿S HAND. THE CUSTOMER ALSO STATED THAT THEY COULD NOT SEE IF THE FILTER CRACKED, AND THIS HAPPENED NUMEROUS TIMES. THE ISSUE WAS NOTICED DURING INFUSION AT APPROXIMATELY 12 HOURS POST TO THE START OF INFUSION. WHEN ASKED IF THERE WAS MEDICAL INTERVENTION REQUIRED, IT WAS MENTIONED THAT THEY NEED TO GET A NEW BAG OF CHEMO WITH NEW TUBING AND RESTART THE INFUSION, SO THE INFUSION WAS PAUSED DURING THIS TIME. THERE WAS PATIENT INVOLVEMENT BUT NO REPORT OF HUMAN HARM. THIS IS THE FIRST OF TWO EVENTS.

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

    MAUDE report 15459816 ↗
  • MalfunctionAug 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A NDHP 0.2 MICRN HP CL. THE CUSTOMER REPORTED PRODUCT FAILURES WITH LEAKING CHEMO DRUGS AT THE FILTER. THERE WAS NO REPORT OF HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15328377 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.