ICU Medical 011-C3300Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00840619001421), received between Mar 5, 2020 and Feb 24, 2026 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026No Flow

  EVENT OCCURRED REGARDING A CLAVE NEUTRAL CONNECTOR WHERE THE REPORTER STATED, "BLOOD STUCK IN THE TUBE." THE EVENT OCCURRED DURING INFUSION. THERE WERE NO CONCOMITANT DRUG AND NO CONCOMITANT DEVICE. THERE WAS NO BLEEDBACK, NO CHEMO, NO BIOHAZARD, NO USER FACILITY MEDWATCH, AND NO DEVICE WAS REPROCESSED/RESTERILIZED. NO DELAY IN THERAPY. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429207 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT DURING IV PUSH ADMINISTRATION, LEAKAGE WAS OBSERVED FROM THE BLUE CONNECTOR. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THERE WAS NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293944 ↗
• MalfunctionAug 21, 2025No Flow; No Flow

  EVENT OCCURRED REGARDING A CLAVE NEUTRAL CONNECTOR WHERE THEY REPORTED THAT, "THEY CONNECTED C3300 ON 3-WAY WHICH PUT ON A-LINE. AFTER THEY DREW OFF BLOOD WITH SYRINGE, THE BLOOD STAY BETWEEN THE SILICONE AND THE HOUSING. THEY COULDN¿T FLUSH CLEAR WITH NORMAL SALINE. THERE WAS NO BLEED BACK, NO BIOHAZARD, NO CHEMO." THEY REPORTED THAT FIVE (5) QUANTITY WAS AFFECTED. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861730 ↗
• MalfunctionAug 11, 2025No Flow; No Flow

  EVENT OCCURRED REGARDING A CLAVE NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT C3300 WAS CONNECTED ON 3-WAY WHICH PUT ON A-LINE. AFTER DRAWING BLOOD WITH SYRINGE, THE BLOOD STAYED BETWEEN THE SILICONE AND THE HOUSING AND THEY COULD NOT FLUSH CLEAR WITH NORMAL SALINE. THE ALSO MENTIONED THAT THERE WAS NO DEFECTS ON THE PRODUCT AND THERAPY RESUMED WITHOUT ANY FURTHER ISSUES AFTER REPLACING WITH A NEW ONE. ONLY ONE (1) SAMPLE WAS REPORTED TO BE AFFECTED. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779306 ↗
• MalfunctionAug 7, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A CLAVE NEUTRAL CONNECTOR WHERE THEY REPORTED LEAKAGE WITH THE CONNECTOR WHICH WAS CONNECTED TO A SYRINGE. THEY LISTED FIVE POSSIBLE LOTS THAT COULD HAVE BEEN AFFECTED BUT ARE NOT SURE OF THE PARTICULAR LOT. ONLY ONE (1) DEVICE WAS REPORTED TO BE AFFECTED. THE COMPLAINT STATED THAT THE LEAK WAS NOTED AT THE START OF ASPIRATION, AND IT WAS CONFIRMED THAT THE SUBSTANCE LEAKING FROM THE PRODUCT WAS BLOOD. NORMAL SALINE WAS USED AS THE SOLUTION. A CRACK WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT, BUT NO ONE WAS HARMED. THERE WAS NO UNPROTECTED DRUG EXPOSURE TO THE PATIENT OR HEALTHCARE PROVIDERS. THE PRODUCT WAS REPLACED, AND THERAPY RESUMED WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739314 ↗
• MalfunctionJul 17, 2025Blocked Connection; No Flow; Blocked Connection; No Flow

  EVENT INVOLVES A CLAVE¿ NEUTRAL CONNECTOR INTRAVENOUS CATHETER + Y-SITE EXTENSION SET +INFUSION SET WHERE THE REPORTER STATED THAT AN OBSTRUCTION- BLOOD, WAS STUCK IN THE CLAVE DURING THE INFUSION. THEY SATED THAT THE DRUGS INVOLVED WERE ANESTHETICS, GLUCOSE, OR ANTIBIOTICS. THERE WAS NO BLEEDBACK REPORTED. THERE WAS NO PATIENT HARM/ADVERSE AND NO DELAY IN CRITICAL THERAPY EVENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22537194 ↗
• MalfunctionJun 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A CLAVE¿ NEUTRAL CONNECTOR REPORTEDLY LEAKED AT THE CONNECTOR, DESPITE ALL EXTERNAL CONNECTIONS BEING SECURELY IN PLACE. THIS LEAKAGE RESULTED IN A SUDDEN DROP IN BLOOD SUGAR LEVEL OF THE PATIENT. UPON FURTHER INVESTIGATION, THEY DISCOVERED THAT THE ISSUE ORIGINATED FROM THE VALVE CONNECTOR ITSELF. NOTABLY, THE DEFECT WAS NOT IMMEDIATELY VISIBLE AND ONLY BECAME APPARENT WHEN THE CONNECTOR WAS FLUSHED INDEPENDENTLY, WITHOUT BEING ATTACHED TO THE OTHER COMPONENTS. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: Hypoglycemia

  MAUDE report 22332474 ↗
• MalfunctionMay 27, 2025Fracture; Fracture

  THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR WHERE IT WAS REPORTED THERE WAS A BROKEN NEEDLELESS CONNECTOR WHICH WAS FOUND DURING CONTINUOUS INFUSION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090015 ↗
• MalfunctionMar 24, 2025Crack; Crack

  THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR WHERE THE CUSTOMER REPORTED THAT SOME UNITS, NOT ALL FROM THE SAME BOX, DEVELOPED CRACKS WHEN CONNECTED TO THE SYRINGE. NO MEDICATIONS WERE ADMINISTERED DURING THE USE OF THE PRODUCTS, AND THE PRODUCTS WERE NEITHER REPROCESSED NOR RE-STERILIZED PRIOR TO USE. THE EVENT OCCURRED DURING PATIENT USE, WHEN THE SYRINGE WAS INSERTED IN THE CONNECTOR; THERE WAS NO HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677987 ↗
• MalfunctionJan 15, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR THAT REPORTEDLY LEAKED DURING INFUSION, AS A RESULT OF A LOOSE/LAX CONNECTION AT THE INFUSION JOINT AT 10:00. THE STAFF USED THE INFUSION JOINT DURING THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) DRESSING CHANGE FOR THE PATIENT. THE DEVICE COULD NOT BE USED, RESULTING IN WASTE OF CONSUMABLES. IF A DEVICE CANNOT BE USED, A NEW INFUSION JOINT SHOULD BE REPLACED IMMEDIATELY FOR THE USE OF THE PATIENT. THERE WAS NO REPORT OF ANY HUMAN HARM ASSOCIATED WITH THE COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163335 ↗
• MalfunctionDec 4, 2024No Flow; No Flow

  THE EVENT INVOLVED A MICROCLAVE® CONNECTOR WHERE IT WAS REPORTED THAT THE STAFF FOUND THAT WHEN USING THE INFUSION JOINT, THE WATER COULD NOT BE PUSHED OUT- REPLACE IT IMMEDIATELY. THE INTENTION FOR USE WAS "IV BAG AND IV TUBE". THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843824 ↗
• MalfunctionSep 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A MICROCLAVE® CONNECTOR WHERE THE CUSTOMER REPORTED THAT THE INFUSION JOINT IS NOT SCREWED TIGHTLY AND WHEN THE NURSE REPLACED THE INFUSION JOINT TO THE PATIENT, THE SCREW WAS NOT TIGHT, AND THE MEDICINE LEAKED OUT, AND THE REPLACEMENT OF THE NEW INFUSION JOINT WAS IMMEDIATELY STOPPED. 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 20334599 ↗
• MalfunctionSep 10, 2024Crack; Crack

  IT WAS REPORTED THAT A CLAVE¿ NEUTRAL CONNECTOR DEVICE WAS FOUND TO BREAK DURING PATIENT USE. THE REPORTER STATED "THE TIP OF THE MICROCLAVE CONNECTOR HAS BROKEN OFF, INTERRUPTING INFUSION. THIS PROBLEM OCCURS SINCE THE PRODUCT HAS CHANGED; THE BLUE PART IS MADE OF A DIFFERENT MATERIAL THAN BEFORE. THE EVENT HAPPENED DURING PRIMING. NO BLOOD LOSS AND NO UNPROTECTED CHEMO EXPOSURE. THERE WAS A DELAY IN CRITICAL THERAPY BUT NO ADVERSE EVENT HAPPENED. NO ADVERSE OPERATOR CONSEQUENCES, NO MED/SURG INTERVENTION REQUIRED. THE DEVICE(S) WERE NOT CHANGED OUT/REPLACED TO CHECK IF THERE WERE NO FURTHER PROBLEMS ENCOUNTERED. INVOLVED DEVICE(S) IS NOT AVAILABLE TO BE TESTED. THE SAME LOT OF DEVICE SAMPLES ARE AVAILABLE. MATING DEVICE(S) AVAILABLE TO BE TESTED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20186889 ↗
• MalfunctionAug 13, 2024Contamination; Contamination

  AN EVENT A MICROCLAVE¿ CONNECTOR EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE REPORTER STATED, ¿THE PICC WAS CONNECTED TO 01C-C3300 INFUSION, AND THE PICC WAS BLOCKED ON THE THIRD DAY. INFUSION CANNOT CONTINUE AFTER REPLACEMENT OF INFUSION JOINT. THE NURSE PULLED OUT AND EXAMINED THE PICC AND FOUND A FOREIGN OBJECT IN THE PICC, WHICH WAS CLEAR AND ELASTIC AND SUSPECTED TO BE PART OF 01C-C3300." IT WAS STATED IN THE REPORT THAT THE EVENT WAS NOT DETECTED PRIOR TO DIRECT PATIENT USE. THE EVENT OCCURRED DURING INFUSION WITH PICC AS MATING DEVICE INVOLVED. THE DEVICE WAS USED FOR 48 HOURS. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, NO ADVERSE OPERATOR CONSEQUENCES AND NO MED/SURG INTERVENTION REQUIRED. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE IS 1 INVOLVED PROBLEMATIC DEVICE THAT IS AVAILABLE TO BE TESTED AND BEING RETURNED FOR INVESTIGATION. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY. UPDATE: THE CUSTOMER SENT ICU MEDICAL ADDITIONAL SAMPLE PHOTOS CONFIRMING THE FOREIGN MATTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974420 ↗
• MalfunctionJun 17, 2024Material Separation; Material Separation

  INT'L.(UK) COMPLAINT RECEIVED REPORTING COMPONENT ISSUES WITH USE OF 011-C3300 MICROCLAVE CONNECTORS AND VARIOUS PICC AND CENTRAL LINE SET-UPS. THE FACILITY WAS TRIALING THE MICROCLAVE CONNECTORS (DEC. 2013 - JAN. 2014) AND REPORTED TWO COMPONENT RELATED ISSUES WHERE IN ONE INSTANCE THE SILICONE PLUG WAS RECESSED AND ONE INSTANCE WHERE THE SILICONE PLUG WAS PROTRUDING. THE MICROCLAVE CONNECTORS WERE SUCCESSFULLY PRETESTED/PRIMED AND USED WITHOUT INCIDENT IN MULTIPLE INFUSION TREATMENTS PRIOR TO THE COMPONENT RESET ISSUES THAT OCCURRED. RELATED USAGE/SET-UP INFORMATION REPORTS THE CONNECTORS WERE ACCESSED/MATED WITH 10ML LUER LOCK SYRINGES; ANTI-SYPHON SYRINGE GIVING SETS. THE MICROCLAVE CONNECTORS WERE REMOVED AND REPLACED WITH NO ADVERSE PATIENT CONSEQUENCES AND OR OUTCOMES. DEVICE RETURN: TWO (2) USED 011-C3300, MICROCLAVE CONNECTORS. NO MATING/ACCESS DEVICES WERE RETURNED. VISUAL INSPECTION OF THE AS-RECEIVED DEVICES RECORDED ONE MICROCLAVE CONNECTORS SILICONE PLUG WAS PROTRUDED AND ONE MICROCLAVE SILICONE PLUG WAS RECESSED. THE REPORTED PRODUCT ISSUES WERE VISUALLY CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554770 ↗
• MalfunctionJun 8, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE COMPLAINT/EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR THAT WAS REPORTED AS FAULTY AND UNABLE TO BE CLEANED EFFECTIVELY PRIOR TO ADMINISTRATION/INFUSION. THIS WAS DUE TO THE MIDDLE PART (BUNG) HAD POPPED IN ON ITSELF, AND DUST AND DIRT WAS COLLECTING INSIDE THE BUNG. THE PATIENT WAS RECEIVING TREATMENT FOR A CENTRAL LINE INFECTION AT THE TIME OF THE COMPLAINT/EVENT. THE BUNG WAS CHANGED OUT/REPLACED WHEN THE DEFECT WAS NOTED. SUBSEQUENT TO THE INITIAL COMPLAINT REPORT, THE CUSTOMER PROVIDED ADDITIONAL INFORMATION CONFIRMING THAT THE PATIENT WAS BEING TREATED FOR A CENTRAL LINE INFECTION PRIOR TO THE COMPLAINT EVENT AND THAT THEY ARE NOT ALLEGING A CENTRAL LINE BLOODSTREAM INFECTION AS A RESULT OF THE COMPLAINT. THE CUSTOMER STATED THAT THERE WAS NO PATIENT HARM SINCE DEVICE WAS CHANGED OUT/REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19494836 ↗
• InjuryJun 7, 2024No Flow; No Flow

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A CLAVE¿ NEUTRAL CONNECTOR GENERATED A NO-FLOW EVENT DURING PATIENT USE. THE INITIAL REPORT STATED THAT IN THE VASCULAR UNIT OF THE HOSPITAL, ISSUES WITH THE CONNECTOR WHEN BEGINNING AN INFUSION WERE NOTED. WHEN THE LUER LOCK SYRINGE WITH SALINE SOLUTION WAS CONNECTED A FLUSH WAS UNABLE TO BE PERFORMED BECAUSE IT DID NOT ALLOW THE CONNECTOR TO INFUSE. IN SOME CASES, THE INTRAVENOUS TUBING (IV) HAS BEEN REMOVED FROM THE PATIENT CONSIDERING THAT THIS WAS THE PROBLEM, HOWEVER, WHEN THE CONNECTOR WAS REPLACED, IT WORKED. THERE ARE TWO AFFECTED SAMPLES AVAILABLE FOR EVALUATION. THE PRODUCT IS NOT CONTAMINATED, LOW BIOHAZARD OR CONTAINED A CHEMOTHERAPEUTIC AGENT, AND IT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. NO MEDICATION WAS USED WHILE USING THE CONNECTOR. THE PATIENT¿S IV AND CATHETER WERE CHANGED AS A RESULT OF THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483859 ↗
• MalfunctionJun 4, 2024No Flow; No Flow

  THE EVENT INVOLVED CLAVE¿ NEUTRAL CONNECTOR WHERE THE CUSTOMER REPORTED THAT THE DEVICE WAS UNABLE TO INFUSE DURING PATIENT USE. THE CUSTOMER REPORTED THAT ON VASCULAR UNIT OF HOSPITAL 3RD B THEY WERE HAVING ISSUES WITH THE CONNECTOR WHEN GOING TO INFUSE, IT HAS ALSO OCCURRED WHEN PUMP SETS (LUER LOCK) WHERE CONNECTED, SO THE 1/4 TURN OF THE CONNECTION MANEUVER DIDN¿T HAPPEN. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CONNECTOR FAILED TO INFUSE WHEN A PUMP SET WITH LUER LOCK CONNECTION WAS CONNECTED. THERE WAS PATIENT INVOLVEMENT SINCE THEY HAD THE PATIENT IV CHANGED. NO MEDICATION WAS USED WHILE USING THE CONNECTOR. THERE WAS NO DELAY IN THERAPY, THERE WAS NO ADVERSE EVENT, AND NO ONE WAS HARMED AS A RESULT OF THIS EVENT. THE EVENT OCCURRED AT THE END OF THE MONTH OF APRIL, BUT SPECIFIC DATE IS UNKNOWN. THERE WAS NO HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464388 ↗
• MalfunctionJun 4, 2024Disconnection; Disconnection

  THE COMPLAINT/EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR THAT REPORTEDLY POPPED OFF EASILY WHEN CONNECTED TO AN UNSPECIFIED EXTENSION SET DURING AN INFUSION. THE CUSTOMER INDICATED THAT THE DEVICE FELT MORE OILY. THERE WAS NO CONCOMITANT DRUG OR CHEMOTHERAPY INVOLVED, NO BLEEDBACK, NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462944 ↗
• MalfunctionMar 20, 2024No Flow; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CLAVE¿ NEUTRAL CONNECTOR WHERE THE CUSTOMER REPORTED THAT THE DEVICE WAS UNABLE TO FLOW FROM THE FILTER DURING PATIENT INFUSION OF INFLIXIMAB, CAUSING DELAY IN THERAPY. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, NO DELAY IN CRITICAL THERAPY NO ADVERSE OPERATOR CONSEQUENCES , NO MED/SURG INTERVENTION REQUIRED AND NO INVOLVED DEVICE AVAILABLE TO BE TESTED. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943546 ↗
• MalfunctionFeb 14, 2024Material Separation; Material Separation

  THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR WHERE IT WAS REPORTED THE BLUE COMPONENT WAS COMING APART FROM THE BODY OF THE CONNECTOR, RENDERING IT UNUSABLE AND MEANING THE BUNG HAD TO BE REPLACED. THE STATUS OF THE PRODUCT AT TIME OF EVENT WAS DURING INFUSION DURING INDUCTION OF A PATIENT UNDERGOING GENERAL ANESTHESIA. THERE WAS NO SERIOUS INJURY, NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, ADVERSE OPERATOR CONSEQUENCES, AND NO MED/SURG INTERVENTION REQUIRED. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THE CUSTOMER STATED THE CLEAR PLASTIC BUNGS SEEM A COURSER CASTING AND SEEM PRONE TO BE CROSS THREADED. THEY USED TO THE OPAQUE MAT BLUE BUNGS WHICH CAN CROSS THREAD TOO, BUT THE CLEAR ONES SEEM EASIER TO CROSS THREAD. THEY HAVE NEVER PREVIOUSLY BEEN ABLE TO REMOVE THE BODY OF THE BUNG WHILE UN-ATTACHING A SYRINGE. THE MEDICATION INVOLVED IN THE EVENT IS ONLY INTRAVENOUS (IV) HARTMANNS. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702969 ↗
• MalfunctionDec 13, 2023No Flow; No Flow

  THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR. IT WAS REPORTED ON SEVERAL OCCASIONS AND WITH DIFFERENT OPERATORS, THEY FAILED TO INFUSE THE CONNECTED LIQUID AND HAD A DIFFICULT CONNECTION TO THE LUER LOCK FITTING. THE CUSTOMER INFORMED THAT THE EVENT TOOK PLACE DURING PATIENT USE BUT NOBODY WAS HARMED AS A RESULT OF THIS EVENT. THERE WAS NO DELAY IN THERAPY. THE DRUG USED IS ¿ANTIBIOTIC¿. THE TUBING SET UP WAS AS IT FOLLOWS: INFUSION BAG INFUSION SET CLAVE CONNECTOR VENFLON. NO LEAK NOTED FOLLOWING THIS EVENT. THERE WAS NO BLOOD LOSS. THE MEDICATION USED WAS SALINE SOLUTION. NO DEFECTS, CUTS OR HOLES NOTED. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT IS DURING INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320752 ↗
• MalfunctionNov 28, 2023Disconnection; No Flow; Disconnection; No Flow

  THE INCIDENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR ON AN UNKNOWN DATE. THE REPORTER STATED THAT THE CONNECTION THREAD TO THE SETS IS DEFECTIVE AND THE INFUSION SETS DETACH FROM THE DEVICE EVEN THOUGH THEY ARE ATTACHED CORRECTLY. FURTHERMORE, IF USED TO ASPIRATE FROM THE LINE THEY DO NOT SUPPLY BLOOD GIVING THE IDEA OF AN OCCLUSION BUT THE ACCESS IS PATENT. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO REPORT OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220540 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR, WHERE IT WAS REPORTED THAT THE CONNECTOR WAS LEAKING FROM WHERE THE CLEAR PART AND BLUE PART OF THE CONNECTOR MARRY UP. THE PRODUCT PROBLEM OCCURRED DURING INFUSION OF TOTAL PARENTERAL NUTRITION (TPN) AND THE LENGTH OF TIME THE DEVICE WAS IN USE WAS 1 HOUR. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM. THE DEVICE WAS NOT CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THIS CAPTURES THE SIX OF SIX OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17227360 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR, WHERE IT WAS REPORTED THAT THE CONNECTOR WAS LEAKING FROM WHERE THE CLEAR PART AND BLUE PART OF THE CONNECTOR MARRY UP. THE PRODUCT PROBLEM OCCURRED DURING INFUSION OF TOTAL PARENTERAL NUTRITION (TPN) AND THE LENGTH OF TIME THE DEVICE WAS IN USE WAS 1 HOUR. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM. THE DEVICE WAS NOT CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THIS CAPTURES THE FIVE OF SIX OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17227356 ↗

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-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-0690-2014 · Dec 24, 2013 · Terminated
  6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock, Part No. A1000, Item No. K7097-001 The ICU Needleless Connector is a single use, sterile, no
• 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-0676-2014 · Dec 24, 2013 · Terminated
  13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave, Rotating Luer, Part No. A1000, Item No. A1080 The ICU Needleless Connector is a single use, sterile, non-py
• Z-0707-2014 · Dec 24, 2013 · Terminated
  17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lot # 2796668. The ICU Needleless Connector
• 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-0664-2014 · Dec 24, 2013 · Terminated
  NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular
• Z-0681-2014 · Dec 24, 2013 · Terminated
  6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 The ICU Needleless Connector is a single use, sterile, no
• Z-0668-2014 · Dec 24, 2013 · Terminated
  7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE Clear, NanoClave T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1009 The ICU Needleless Connector is a sin
• Z-0695-2014 · Dec 24, 2013 · Terminated
  11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connector is a single use, sterile, non
• 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-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-0669-2014 · Dec 24, 2013 · Terminated
  8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1014 The ICU Needleless Con
• Z-0691-2014 · Dec 24, 2013 · Terminated
  7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7099-001 The ICU Needleless Connector is a single use, sterile, non-pyrog

…and 37 more.