ICU Medical C1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00840619069896), received between Feb 6, 2023 and Apr 16, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (20 reports).

52 other recalls cover devices cleared under the same FDA submission (K970855); 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A CLAVE CONNECTOR, AND IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO ADMINISTER A RADIOACTIVE MEDICATION THROUGH THE BLUE CLAVE INTO A POWER PORT. WHILE THE MEDICATION WAS BEING PUSHED, THE CLAVE CONNECTOR LEAKED AND SQUIRTED THE MEDICATION ONTO THE PATIENT AND STAFF. STAFF CONFIRMED THAT THE MEDICATION SYRINGE WAS FULLY TWISTED AND CONNECTED TO THE CLAVE. THE CLAVE WAS SECURELY ATTACHED TO THE POWER PORT LINE. THE PATIENT DID NOT RECEIVE THE INTENDED RADIOACTIVE MEDICINE AND HAD TO BE RESCHEDULED, AS THERE WAS NO ADDITIONAL SUPPLY OF THE MEDICATION. THERE WAS PATIENT INVOLVEMENT, AND NO HARM.

  Patient problems: Chemical Exposure

  MAUDE report 24902164 ↗
• MalfunctionMar 3, 2026No Flow; No Apparent Adverse Event

  ADDITIONAL INFORMATION WAS RECEIVED ON 03MAR2026 AS FOLLOWS: THE CUSTOMER'S REPORTED ISSUE OCCURRED DURING PRIMING. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494244 ↗
• MalfunctionSep 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED ON AN UNKNOWN DATE REGARDING A CLAVE® CONNECTOR WHERE THE REPORTER STATED THAT "THERE APPEARED TO BE A CLAVE MALFUNCTION WITH A CENTRAL LINE WHICH WAS INFUSING A CHEMOTHERAPY AGENT. THE SPIROS TUBING CONNECTION REMAINED INTACT. IT WAS DETERMINED WITH THE HELP OF THE CHARGE NURSE THAT THE CLAVE ITSELF WAS LEAKING AND WHEN IT WAS DISCONNECTED APPEARED TO BE DEFECTIVE. THE CLAVE WAS CHANGED AND THE PROBLEM RESOLVED." THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033687 ↗
• MalfunctionSep 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CLAVE® CONNECTOR WHERE THE CUSTOMER REPORTED THAT THE CLAVE LUER WAS PERMANENTLY PUSHED IN CAUSING A SMALL LEAK AT THE CONNECTION. CLAVE WAS CHANGED AND CHEMOTHERAPY WAS RESUMED. THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955354 ↗
• MalfunctionJul 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT INVOLVED A CLAVE¿ CONNECTOR WHERE THEY REPORTED THAT CLAVE CONNECTER BLUE KNOBS LEAKS. THEY SAID A FEW INCIDENTS HAVE OCCURRED WITHIN THE PAST MONTH. THE REPORTER STATED THAT THE HUB BECOMES STUCK UNPREDICTABLY AND LEAKS OUT FLUID DURING INFUSION. THE PROCEDURES WERE COMPLETED, AND THE TESTS WERE STILL IN DIAGNOSTIC LEVEL SO THERE WAS NO DELAY IN DIAGNOSIS OR TREATMENT. THE CLAVE WHICH WAS DIRECTLY CONNECTED TO THE PATIENTS IV. WAS PREVIOUSLY ATTACHED TO STOP-COCK/TUBING SERIES FOR MORNING STRESS TEST AND WAS THEN DISCONNECTED FOR REST TEST WHEN THE TRACER LEAKAGE OCCURRED. THEY STATED THAT THE CLAVE WAS NOT ACCESSED WITH A BLUNT OR SHARP BUT WAS ONLY ACCESSED WITHIN THE TARGET AREA. THE CLAVE SITE WHERE THE LEAK NOTED WAS AT PERIPHERAL IV - LEFT ACF. THE SYRINGE WAS DIRECTLY ATTACHED TO CLAVE. NO IMPACT ON THE PATIENT OR HEALTHCARE PROVIDER, ONLY A SMALL DROP WAS SPILLED ON THE PATIENT'S ARM BUT WAS CLEANED WITH AN ALCOHOL SWAB AND THE SUPPLIES WERE PLACED IN RADIOACTIVE GARBAGE AFTERWARDS. THE MAJORITY OF THE DOSE WENT THROUGH THE IV AND WAS COLLECTED IN THE PATIENT'S HEART, SO THE PATIENT DID NOT RECEIVE ANY ADDITIONAL RADIATION AS A RESULT. THE RADIOACTIVE SPILL WAS CLEAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668143 ↗
• MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CLAVE¿ CONNECTOR WHERE THE CUSTOMER REPORTED THAT THE DEVICE LEAKED DURING PATIENT USE. THE CUSTOMER STATED THAT THERE WAS NO APPARENT HARM TO THE PATIENT BUT S/HE DID GET SATURATED CLOTHING IN LAP AND WAS EXPOSED TO A HAZARDOUS MEDICATION IN THE CLINIC. THE CENTER OF THE CLAVE (WHITE IN COLOR) APPEARED TO BE SQUASHED BACK INTO THE CLAVE, AND WHEN THE ATTACHED TUBING WAS REMOVED, THE CLAVE'S WHITE CENTER USUALLY RETURNS TO CENTER TO CLOSE BUT IT STAYED RETRACTED. THERE WAS MINIMAL DELAY IN THERAPY. THE INFUSION WAS STOPPED, THE LINE WAS INSPECTED AND THE CLAVE WAS NOTED TO BE BROKEN; THE CENTER OF THE CLAVE APPEARED TO BE PUSHED BACK INTO THE CLAVE WHEN LINE WAS ATTACHED. INFUSION WAS IN PROCESS FOR APPROXIMATELY 5 MINUTES; USING CHEMO PRECAUTIONS PRIMARY LINE WAS REPLACED AND PATIENT CHANGED CLOTHING. THE FAULTY EQUIPMENT WAS BAGGED AND GIVEN TO THE FLOOR MANAGER. THE CUSTOMER FURTHER REPORTED THAT THE ICU MEDICAL 360 PLUM PUMP WAS USED. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: Chemical Exposure

  MAUDE report 22653735 ↗
• MalfunctionJul 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A CLAVE¿ CONNECTOR GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT MULTIPLE OCCURRENCES OF FAILED CONNECTIONS LED TO LEAKING MEDICATION. THE EVENT OCCURRED DURING PATIENT USE. NO APPARENT HARM TO THE PATIENT. THE SITUATION WITH THE HOME INFUSION PUMP WAS DISCOVERED THE NEXT DAY WHEN THE PATIENT REPORTED NO MEDICATION HAD INFUSED. THE CENTER OF THE CLAVE (WHITE) APPEARED TO BE SQUISHED BACK INTO THE CLAVE, WHEN THE ATTACHED TUBING WAS REMOVED, THE CLAVE'S WHITE CENTER USUALLY RETURNS TO CENTER TO CLOSE. IT STAYED RETRACTED. THERE WAS A DELAY IN THERAPY AS THE PUMP PATIENT HAD TO HAVE A NEW PUMP MIXED AND START OVER WITH HER 2-DAY INFUSION. THIS RESULTED IN PUSHING HER TREATMENT OUT BY TWO DAYS. PUMP PATIENT ALSO HAD THE WHOLE DOSE WASTED, AND A NEW DOSE AND EQUIPMENT WERE USED. ADDITIONAL REPORT STATED THAT THEY RECEIVED FOLFIRINOX ON WEDNESDAY, 18-JUN-2025, WHICH INCLUDED 5FU PUMP STARTING AT 15:15. THE REGISTERED NURSE (RN) NOTED A BRISK BLOOD RETURN FROM THE PORT BEFORE CONNECTING THE HOME INFUSION. CONNECTIONS CHECKED AND TIGHTENED. ON THURSDAY, (B)(6) 2025, THE PATIENT'S SIGNIFICANT OTHER CALLED AND SPOKE WITH THE ON-C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572276 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A CLAVE® CONNECTOR REPORTEDLY LEAKED AROUND THE SCREW-IN PIECE OF THE CONNECTION/THREAD A FEW WEEKS AGO. THIS ISSUE HAPPENED APPROXIMATELY SOME TIME AROUND (B)(6) 2025. THEY HAVE 2 BOXES OF THE SAID LOT NUMBER THAT WERE AFFECTED, FOR WHICH THEY HAVE PULLED THE SUPPLY. APPARENTLY, IN ORDERING MORE CLAVE CONNECTORS, THEY WERE STILL RECEIVING SOME QUANTITY/AMOUNT FROM THE SAME LOT NUMBER AND ENCOUNTERED AGAIN THAT AN IV SITE/HUB WAS LEAKING ON A PATIENT AS WELL. NO ONE WAS HARMED AS A RESULT OF EVENT. THE SET UP WAS THEIR NORMAL INSERTION TO THE IV HUB. THE CLAVE CONNECTOR WAS REPLACED. NO HOLE, CUT, TEARS OR ANY DEFECT WAS NOTED. IT WAS ALSO STATED THAT A MATING DEVICE WAS ATTACHED AND SOMETIMES THEY OBSERVED THIS AT THE CT (COMPUTED TOMOGRAPHY) CONNECTOR, AS THE PATIENT WAS ON THE CT TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545932 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A CLAVE® CONNECTOR REPORTEDLY LEAKED AN UNSPECIFIED FLUID AROUND THE SCREW IN PIECE OF THE CONNECTION/THREAD. THEY HAVE 2 BOXES OF THE SAID LOT NUMBER THAT WERE AFFECTED, FOR WHICH THEY HAVE PULLED THE SUPPLY. APPARENTLY, IN ORDERING MORE CLAVE CONNECTORS, THEY WERE STILL RECEIVING SOME QUANTITY/AMOUNT FROM THE SAME LOT NUMBER AND ENCOUNTERED AGAIN THAT AN IV SITE/HUB WAS LEAKING ON A PATIENT AS WELL. NO ONE WAS HARMED AS A RESULT OF EVENT. THE SET UP WAS THEIR NORMAL INSERTION TO THE IV HUB. THE CLAVE CONNECTOR WAS REPLACED. NO HOLE, CUT, TEARS OR ANY DEFECT WAS NOTED. IT WAS ALSO STATED THAT A MATING DEVICE WAS ATTACHED AND SOMETIMES THEY OBSERVED THIS AT THE CT (COMPUTED TOMOGRAPHY) CONNECTOR, AS THE PATIENT WAS ON THE CT TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545770 ↗
• MalfunctionJul 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A CLAVE¿ CONNECTOR THAT EXPERIENCED LEAKAGE DURING INFUSION. THE REPORT STATES THAT DURING THE PAST MONTH A FEW INCIDENTS WITH THE CLAVE CONNECTER BLUE KNOBS LEAKING. THE HUB BECOMES STUCK UNPREDICTABLY AND LEAKS OUT FLUID. THE CUSTOMER ALSO STATED THAT RADIOACTIVE TRACER LEAKING ONTO A PATIENT'S ARM AS A RESULT. THE DATE OF INCIDENT WAS ON (B)(6) 2025 DURING INFUSION. THE PROCEDURES WERE COMPLETED. THE TESTS WERE STILL DIAGNOSTIC LEVEL. NO DELAY IN DIAGNOSIS OR TREATMENT. THE CLAVE WAS ATTACHED TO A STOP-COCK WHICH WAS ATTACHED TO A SERIES OF TUBING AND OTHER STOP-COCKS. IT WAS NOT ACCESSED WITH A BLUNT OR SHARP. IT WAS ACCESSED WITHIN THE TARGET AREA. THE CLAVE WAS DIRECTLY CONNECTED TO THE PATIENT'S IV. THE CLAVE SITE WAS ON PERIPHERAL IV - LEFT ACF. NO IMPACT ON THE PATIENT OR HEALTHCARE PROVIDER, ONLY A SMALL DROP WAS SPILLED ON THE PATIENT, THE MAJORITY OF THE DOSE WENT THROUGH THE IV AND WAS COLLECTED IN THE PATIENT'S HEART. THE TEST WAS STILL DIAGNOSTIC, AND THE PATIENT DID NOT RECEIVE ANY ADDITIONAL RADIATION AS A RESULT. NO CONTAMINATION WAS FOUND ON ANY SURFACE AFTERWARDS. THE RADIOACTIVE SPILL WAS CLEANED UP PER FACILITY PROTOCOL. SPIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22526801 ↗
• MalfunctionJul 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A CLAVE¿ CONNECTOR THAT EXPERIENCED LEAKAGE. THE REPORTER STATED WHEN THE PRODUCT C1000 WAS CONNECTED TO CH2000S-C IT WAS LEAKING CHEMOTHERAPY AROUND THE LUER THREADS OF THE C1000. THIS EVENT HAPPENED SEVERAL TIMES WITH THE SAME LOT NUMBER. HE ALSO CONFIRMED THAT THE CH2000S-C WAS NOT HAVING AN ISSUE AND ONLY THE C1000 WAS EXPERIENCING AN ISSUE. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470384 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CLAVE¿ CONNECTOR. WHEN PUSHING ADENOSINE THROUGH AN UNSPECIFIED 3-WAY STOPCOCK INTO A LINE WITH CLAVE IN BETWEEN, THE DEVICE REPORTEDLY MALFUNCTIONED BY EITHER: 1. SQUIRTING THE FLUID OUT AT THE CONNECTION SITE WHERE THE STOPCOCK ENTERED THE CLAVE OR, 2. THEY COULDN'T PUSH THE FLUID IN AT ALL, MEETING RESISTANCE. IT APPEARED AS THROUGH THE CENTER OF THE CLAVE DID NOT LINE UP WELL WITH THE OPENING OF THE STOPCOCK. THE WORK AROUND DISCOVERED WAS TO REMOVE THE CLAVE AND CONNECT THE STOPCOCK DIRECTING ONTO THE LINE PRIOR TO ADMINISTERING THE ADENOSINE. THERE WAS NO ISSUE OR CONCERN WITH THE UNSPECIFIED 3-WAY STOPCOCK (MATING DEVICE). NO INJURIES OR ADVERSE EVENT. THERE WAS AN UNSPECIFIED DELAY IN THERAPY, THOUGH BRIEF AND UNLIKELY TO HAVE CAUSED NEGATIVE CLINICAL IMPACT TO THE PATIENTS. THIS EMDR REFLECTS 10 OCCURRENCES OF SAME OR SIMILAR EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038637 ↗
• MalfunctionMay 16, 2025No Flow; No Flow

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A CLAVE¿ CONNECTOR WHERE IT WAS REPORTED THAT THE 6SA HAD A STOPCOCK ISSUE WHILE TRYING TO PUSH ADENOSINE. THE WORK AROUND DISCOVERED WAS TO REMOVE THE CLAVE AND CONNECT THE STOPCOCK DIRECTING ONTO THE LINE PRIOR TO ADMINISTERING THE ADENOSINE. A THREE-WAY STOPCOCK IS NOT SPECIFICALLY AN ICU DEVICE, THOUGH IT IS USED IN CRITICAL CARE SETTINGS MORE COMMONLY. NO ISSUE/CONCERN WITH THIS DEVICE. THERE WAS PATIENT INVOLVEMENT AND DELAY IN THERAPY, THOUGH BRIEF AND UNLIKELY TO HAVE CAUSED NEGATIVE CLINICAL IMPACT TO THE PATIENTS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037774 ↗
• MalfunctionApr 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CLAVE® CONNECTOR AND OCCURRED ON AN UNSPECIFIED DATE. IT WAS REPORTED THAT CHEMOTHERAPY SPILLED OUT OF THE CLAVE AND ONTO THE PATIENT. THE CHEMO CAME IN CONTACT WITH PATIENT AND WITH UNPROTECTED CHEMO EXPOSURE TO THE PATIENT. THE HEALTHCARE PROVIDER WEARING PPE. CHEMO WAS ON SHIRT AND SKIN, SHIRT REMOVED, AND SKIN AREA CLEANSED WITH SOAP AND WATER. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THE LEAKAGE NOTED WITH INJECTION CAP. THE WAS NO REPORT OF ADVERSE EVENT.

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

  MAUDE report 19150138 ↗
• MalfunctionOct 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CLAVE¿ CONNECTOR WHERE IT WAS REPORTED THAT IT WAS INTERMITTENTLY LEAKING DURING POWER INJECTIONS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961180 ↗
• MalfunctionFeb 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CLAVE¿ CONNECTOR WHERE IT WAS REPORTED THE DEVICE LEAKED CHEMOTHERAPY DURING INFUSION AND CAME IN CONTACT WITH THE PATIENT AND NURSE. IT WAS REPORTED THAT THE CONNECTION WAS COMING APART FOR NO REASON. THE LINE WAS NOT PULLED ON AND SPONTANEOUSLY DETACHED FROM THE TUBING LINE. THE DISCONNECTION OCCURRED AT THE CONNECTION SITE BETWEEN CONNECTOR AND EITHER THE TUBING OF PORT OR THE PRIMARY TUBING. THE SET UP WAS THE CONNECTOR WAS CONNECTED DIRECTLY ON THE END OF EITHER THE PATIENT¿S PORT LINE OR PERIPHERAL INTRAVENOUS (IV) LINE. THE PRIMARY TUBING WAS THEN CONNECTED INTO THE LUER LOCK OF THE CONNECTOR. THE CONNECTOR AND TUBING WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WAS PATIENT INVOLVEMENT AND A DELAY IN THERAPY, HOWEVER NO REPORT OF PATIENT HARM. THIS CAPTURES THE SECOND OF TWO OCCURRENCES.

  Patient problems: Chemical Exposure

  MAUDE report 16334137 ↗
• MalfunctionFeb 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CLAVE¿ CONNECTOR WHERE IT WAS REPORTED THE DEVICE LEAKED CHEMOTHERAPY DURING INFUSION AND CAME IN CONTACT WITH THE PATIENT AND NURSE. IT WAS REPORTED THAT THE CONNECTION WAS COMING APART FOR NO REASON. THE LINE WAS NOT PULLED ON AND SPONTANEOUSLY DETACHED FROM THE TUBING LINE. THE DISCONNECTION OCCURRED AT THE CONNECTION SITE BETWEEN CONNECTOR AND EITHER THE TUBING OF PORT OR THE PRIMARY TUBING. THE SET UP WAS THE CONNECTOR WAS CONNECTED DIRECTLY ON THE END OF EITHER THE PATIENT¿S PORT LINE OR PERIPHERAL INTRAVENOUS (IV) LINE. THE PRIMARY TUBING WAS THEN CONNECTED INTO THE LUER LOCK OF THE CONNECTOR. THE CONNECTOR AND TUBING WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WAS PATIENT INVOLVEMENT AND A DELAY IN THERAPY, HOWEVER NO REPORT OF PATIENT HARM. THIS CAPTURES THE FIRST OF TWO OCCURRENCES.

  Patient problems: Chemical Exposure

  MAUDE report 16334127 ↗
• MalfunctionFeb 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON UNSPECIFIED DATES AND INVOLVED CLAVE¿ CONNECTORS WHERE IT WAS REPORTED THAT THE FACILITY HAD 5 INCIDENTS WHERE THE CONNECTION WAS SPONTANEOUSLY DETACHED FROM THE TUBING LINE DURING INFUSION OF TAXOL. THE DISCONNECTION OCCURRED AT CONNECTION SITE BETWEEN CONNECTOR AND TUBING OF PORT (IN SOME CASES) AND PRIMARY TUBING (IN OTHER CASES). THE SET UP WAS THE CONNECTOR WAS ALWAYS CONNECTED DIRECTLY ON THE END OF EITHER THE PATIENT¿S PORT LINE OR PERIPHERAL IV LINE. THE PRIMARY TUBING WAS THEN CONNECTED INTO THE LUER LOCK OF THE CONNECTOR. EACH CASE RESULTED IN COMPLETE DISCONNECTION RESULTING IN LEAKING. THE REPORTER STATED THAT IN EVERY CASE THE CONNECTOR AND TUBING WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM. THIS IS THE SECOND OF FIVE OCCURRENCES.

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

  MAUDE report 16308559 ↗
• MalfunctionFeb 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON UNSPECIFIED DATES AND INVOLVED CLAVE¿ CONNECTORS WHERE IT WAS REPORTED THAT THE FACILITY HAD 5 INCIDENTS WHERE THE CONNECTION WAS SPONTANEOUSLY DETACHED FROM THE TUBING LINE DURING INFUSION OF TAXOL. THE DISCONNECTION OCCURRED AT CONNECTION SITE BETWEEN CONNECTOR AND TUBING OF PORT (IN SOME CASES) AND PRIMARY TUBING (IN OTHER CASES). THE SET UP WAS THE CONNECTOR WAS ALWAYS CONNECTED DIRECTLY ON THE END OF EITHER THE PATIENT¿S PORT LINE OR PERIPHERAL IV LINE. THE PRIMARY TUBING WAS THEN CONNECTED INTO THE LUER LOCK OF THE CONNECTOR. EACH CASE RESULTED IN COMPLETE DISCONNECTION RESULTING IN LEAKING. THE REPORTER STATED THAT IN EVERY CASE THE CONNECTOR AND TUBING WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM. THIS IS THE FIFTH OF FIVE OCCURRENCES.

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

  MAUDE report 16308502 ↗
• MalfunctionFeb 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON UNSPECIFIED DATES AND INVOLVED CLAVE¿ CONNECTORS WHERE IT WAS REPORTED THAT THE FACILITY HAD 5 INCIDENTS WHERE THE CONNECTION WAS SPONTANEOUSLY DETACHED FROM THE TUBING LINE DURING INFUSION OF TAXOL. THE DISCONNECTION OCCURRED AT CONNECTION SITE BETWEEN CONNECTOR AND TUBING OF PORT (IN SOME CASES) AND PRIMARY TUBING (IN OTHER CASES). THE SET UP WAS THE CONNECTOR WAS ALWAYS CONNECTED DIRECTLY ON THE END OF EITHER THE PATIENT¿S PORT LINE OR PERIPHERAL IV LINE. THE PRIMARY TUBING WAS THEN CONNECTED INTO THE LUER LOCK OF THE CONNECTOR. EACH CASE RESULTED IN COMPLETE DISCONNECTION RESULTING IN LEAKING. THE REPORTER STATED THAT IN EVERY CASE THE CONNECTOR AND TUBING WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM. THIS IS THE THIRD OF FIVE OCCURRENCES.

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

  MAUDE report 16308499 ↗
• MalfunctionFeb 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON UNSPECIFIED DATES AND INVOLVED CLAVE¿ CONNECTORS WHERE IT WAS REPORTED THAT THE FACILITY HAD 5 INCIDENTS WHERE THE CONNECTION WAS SPONTANEOUSLY DETACHED FROM THE TUBING LINE DURING INFUSION OF TAXOL. THE DISCONNECTION OCCURRED AT CONNECTION SITE BETWEEN CONNECTOR AND TUBING OF PORT (IN SOME CASES) AND PRIMARY TUBING (IN OTHER CASES). THE SET UP WAS THE CONNECTOR WAS ALWAYS CONNECTED DIRECTLY ON THE END OF EITHER THE PATIENT¿S PORT LINE OR PERIPHERAL IV LINE. THE PRIMARY TUBING WAS THEN CONNECTED INTO THE LUER LOCK OF THE CONNECTOR. EACH CASE RESULTED IN COMPLETE DISCONNECTION RESULTING IN LEAKING. THE REPORTER STATED THAT IN EVERY CASE THE CONNECTOR AND TUBING WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM. THIS IS THE FOURTH OF FIVE OCCURRENCES.

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

  MAUDE report 16308479 ↗
• MalfunctionFeb 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON UNSPECIFIED DATES AND INVOLVED CLAVE¿ CONNECTORS WHERE IT WAS REPORTED THAT THE FACILITY HAD 5 INCIDENTS WHERE THE CONNECTION WAS SPONTANEOUSLY DETACHED FROM THE TUBING LINE DURING INFUSION OF TAXOL. THE DISCONNECTION OCCURRED AT CONNECTION SITE BETWEEN CONNECTOR AND TUBING OF PORT (IN SOME CASES) AND PRIMARY TUBING (IN OTHER CASES). THE SET UP WAS THE CONNECTOR WAS ALWAYS CONNECTED DIRECTLY ON THE END OF EITHER THE PATIENT¿S PORT LINE OR PERIPHERAL IV LINE. THE PRIMARY TUBING WAS THEN CONNECTED INTO THE LUER LOCK OF THE CONNECTOR. EACH CASE RESULTED IN COMPLETE DISCONNECTION RESULTING IN LEAKING. THE REPORTER STATED THAT IN EVERY CASE THE CONNECTOR AND TUBING WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM. THIS IS THE FIRST OF FIVE OCCURRENCES.

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

  MAUDE report 16308395 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970855. One submission often covers many models, so check the product and lot details in each record.

• Z-1722-2022 · Aug 1, 2022 · Open, Classified
  MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration S
• Z-0696-2014 · Dec 24, 2013 · Terminated
  13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer, Part No. A1000, Item No. K7106-001 The ICU
• Z-0678-2014 · Dec 24, 2013 · Terminated
  103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. A1093 The ICU Needleless Connector
• Z-0661-2014 · Dec 24, 2013 · Terminated
  183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave , NanoClave T-Connector, Rotating Luer, Part
• Z-0679-2014 · Dec 24, 2013 · Terminated
  8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use
• Z-0680-2014 · Dec 24, 2013 · Terminated
  6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU Needleless Connector is a single use, sterile,
• Z-0684-2014 · Dec 24, 2013 · Terminated
  7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. K7090-001 The ICU Needleless Connector i
• Z-0673-2014 · Dec 24, 2013 · Terminated
  8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device i
• Z-0683-2014 · Dec 24, 2013 · Terminated
  7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intr
• Z-0659-2014 · Dec 24, 2013 · Terminated
  6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Needleless Connector is a single use, sterile, n
• Z-0686-2014 · Dec 24, 2013 · Terminated
  106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. K7093-001 The ICU Needleless Connect
• Z-0702-2014 · Dec 24, 2013 · Terminated
  5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intende
• Z-0703-2014 · Dec 24, 2013 · Terminated
  5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device int
• Z-0662-2014 · Dec 24, 2013 · Terminated
  184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave, NanoClave TConnector, Rotating Luer, Part No. A1000, Item No. 011-
• Z-0701-2014 · Dec 24, 2013 · Terminated
  5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device in

…and 37 more.