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ICU Medical B3300Recalls & reported problems

Icu Medical, Inc. · MicroClave® Neutral Connector · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This ICU Medical MicroClave neutral connector is a small cap used on central lines and IV ports. The 69 reports mostly describe leaking, cracking, or the cap popping off, sometimes forcing staff to reopen the line. There are no deaths and one injury; 68 reports are malfunctions. No recalls name this device, and reports fell from 24 in the earlier 12 months to 6 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
68
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00840619045593), received between Jul 24, 2017 and Feb 6, 2026 — classified as 1 injury, 67 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (52 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 1 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 2 reportsJul 2024: 3 reportsAug 2024: 4 reportsSep 2024: 2 reportsOct 2024: 0 reportsNov 2024: 3 reportsDec 2024: 10 reportsJan 2025: 1 reportsFeb 2025: 1 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 4 reportsNov 2025: 0 reportsDec 2025: 3 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202610
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fluid/Blood Leak52
  • Crack7
  • No Flow6
  • Disconnection5
  • Break3
  • Leak/Splash3
  • Separation Problem2
  • Air/Gas in Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions48
  • No Consequences Or Impact To Patient9
  • Hemorrhage/Blood Loss/Bleeding4
  • Blood Loss2
  • Chemical Exposure2
  • Inadequate Pain Relief2
  • No Information2
  • Adult Respiratory Distress Syndrome1

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 6, 2026Disconnection

    THE CUSTOMER-REPORTED EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A MICROCLAVE® NEUTRAL CONNECTOR. THE CLAVE ADAPTOR OF THE DEVICE REPORTEDLY DISCONNECTED FROM THE END OF THE PORT TWO DAYS IN A ROW. THE CLAVE ADAPTOR WAS SUCCESSFULLY CONNECTED TO THE END OF THE PORT BOTH TIMES AND WAS RUNNING WITHOUT ISSUE INITIALLY. THE SECOND TIME, THE NURSE WENT TO ACCESS THE PORT AND THE CLAVE POPPED OUT, NO LEAKING OBSERVED AT THIS TIME. THIS OCCURRED WHILE ATTACHED TO THE PATIENT. DURING THIS SECOND OCCURRENCE, THE CLAVE ADAPTER POPPED OFF WHEN THE NURSE WAS ATTACHING THE SYRINGE. THE INVOLVED PATIENT WAS NOT HARMED ALTHOUGH IT WAS UNCLEAR HOW MUCH MEDICATION WAS RECEIVED AS THE FLUID WAS LEAKING OUT. THE HOSPITAL FOR SICK KIDS WAS CONSULTED, AND AN ALTERNATE ANTIBIOTIC WAS GIVEN. THIS EMDR REFLECTS THE SECOND OF TWO OCCURENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24282700 ↗
  • MalfunctionFeb 6, 2026Disconnection; Fluid/Blood Leak

    THE CUSTOMER-REPORTED EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A MICROCLAVE® NEUTRAL CONNECTOR. THE CLAVE ADAPTOR OF THE DEVICE REPORTEDLY DISCONNECTED FROM THE END OF THE PORT TWO DAYS IN A ROW. THE CLAVE ADAPTOR WAS SUCCESSFULLY CONNECTED TO THE END OF THE PORT BOTH TIMES AND WAS RUNNING WITHOUT ISSUE INITIALLY. THE FIRST TIME, DURING ROUTINE IV CHECKS, IT WAS FOUND THAT THE PORT DISCONNECTED. THIS OCCURRED WHILE ATTACHED TO THE PATIENT. THE FIRST CASE WAS THAT THE UNSPECIFIED (ANTIBIOTIC) FLUIDS WERE FOUND LEAKING AROUND THE CONNECTED CLAVE AND PORT. THE INVOLVED PATIENT WAS NOT HARMED ALTHOUGH IT WAS UNCLEAR HOW MUCH MEDICATION WAS RECEIVED AS THE FLUID WAS LEAKING OUT. THE HOSPITAL FOR SICK KIDS WAS CONSULTED, AND AN ALTERNATE ANTIBIOTIC WAS GIVEN. THIS EMDR REFLECTS THE FIRST OF TWO OCCURENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24280777 ↗
  • MalfunctionDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

    AN EVENT INVOLVED A CLAVE NEUTRAL CONNECTOR WHERE THE CUSTOMER REPORTED THAT AFTER RECEIVING MEDICATION THAT REQUIRED A FAST FLUSH, THE CENTRAL VENOUS PRESSURE (CVP) TRANSDUCER WAS NO LONGER READING. AFTER FURTHER INSPECTION, THERE WAS FLUID IN THE MICROCLAVE OUTSIDE OF THE FLUID PATH. THE CUSTOMER STATED THAT THE LINE WAS CENTRAL VENOUS CATHETER (CVC) RIGHT INTERNAL JUGULAR (RIJ) VEIN. THERE WAS PATIENT INVOLVEMENT HOWEVER, THERE WAS NO PATIENT HARM AS A CONSEQUENCE OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23739390 ↗
  • MalfunctionDec 3, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

    THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT ON A SECOND LAB DRAW, IT WAS NOTICED THAT AFTER THE FLUSH THAT THERE WAS WATER POOLING IN THE CAP AND IT LOOKED THAT IT WAS CRACKED AND WAS HARD TO FLUSH. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23708294 ↗
  • MalfunctionDec 2, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

    THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT DURING THE FIRST LAB DRAW ON BLUE LUMEN OF THE RIGHT SUBCLAVIAN CENTRAL VENOUS LINE (CVL) WHEN RETURNING THE WASTE, THE CAP STARTED LEAKING BLOOD AND NOTICED IT WAS CRACKED. THERE WAS NO PATIENT HARM.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

    MAUDE report 23700402 ↗
  • MalfunctionOct 24, 2025Break; Break

    A MICROCLAVE® NEUTRAL CONNECTOR REPORTEDLY BROKE DURING PATIENT USE THREE TIMES. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23384573 ↗
  • MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

    A MICROCLAVE® NEUTRAL CONNECTOR REPORTEDLY FILLED WITH BLOOD AND THEN LEAKED BLOOD OUT FROM THE CAP WHEN DRAWING BACK ON THE PATIENT'S LINE. THE CUSTOMER INDICATED THAT THE CAP MAY HAVE BROKEN FROM THE INSIDE. THERE WAS NO PATIENT HARM.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 23384466 ↗
  • MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

    A MICROCLAVE® NEUTRAL CONNECTOR REPORTEDLY FILLED WITH BLOOD AND THEN LEAKED BLOOD INTO THE VALGUARD AND ONTO THE LINEN. 30 MINUTES AFTER PLACING THIS DEVICE ONTO THE PATIENT'S LINE, IT WAS FOUND TO BE FAULTY. THERE WAS NO PATIENT HARM.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 23383447 ↗
  • MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

    DURING DRAWING LABS AND GIVING BACK THE WASTE TO PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) VIA THE RED LUMEN, A CLAVE¿ NEUTRAL CONNECTOR REPORTEDLY LEAKED OUT THE PATIENT'S BLOOD BETWEEN THE 'CAP' AND THE LUMEN. THE CAP WAS NOT LOOSE, AND BLOOD POOLED INSIDE THE CAP. THERE WAS NO PATIENT HARM.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 23380395 ↗
  • InjurySep 9, 2025Crack; Failure to Deliver; No Flow; Crack; Failure to Deliver; No Flow

    EVENT OCCURRED REGARDING A CLAVE¿ NEUTRAL CONNECTOR WHERE THE REPORTER STATED THAT "THERE WAS CRACKED NAD (NEEDLESS ACCESS DEVICE). THEREFORE, THE PATIENT WAS NOT RECEIVING PGE (PROSTAGLANDIN E), AND THIS CAUSED THE PATIENT TO DESATURATE. THEY ALSO STATED THAT THE PATIENT HAS TETRALOGY OF FALLOT AND NEEDS PGE TO KEEP THE DUCT OPEN. THE PATIENT NEEDS MEDICATION TO INFUSE AT ALL TIMES TO PREVENT THE DUCT FROM CLOSING. THE PATIENT DID NOT RECEIVED MEDICATION FOR 30-45 MINUTES RESULTING THE PATIENT TO EXPERIENCE DESATURATING. THE PATIENT NEEDED INCREASE IN FIO2 AND FLOW. PATIENT'S VITAL SIGNS WERE STABLE PRIOR TO THE CRACKED NAD. STILL, THE PATIENT WAS DESATURATING, UNTIL THE NEW NAD WAS PUT IN THE LINE AND THEN PATIENT WAS FINE AFTER PUTTING THE NEW NAD. IT WAS ALSO STATED THAT THEY WENT ON PATIENT'S HIGH FLOW NASAL CANNULA FLOW AND OXYGEN. THEY INCREASED THE PGE DRIP RATE UNTIL THE PATIENT'S VITAL SIGNS WERE STABLE. INTERVENTION WAS REQUIRED. THUS, THERE WAS INJURY AND THERE WAS NO DEATH."

    Patient problems: Adult Respiratory Distress Syndrome; Low Oxygen Saturation

    MAUDE report 23000053 ↗
  • MalfunctionJul 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

    A CLAVE¿ NEUTRAL CONNECTOR WAS REPORTEDLY LEAKING BIVALIRUDIN AT THE CONNECTION OF THE TUBING AND THE CLAVE AT THE PUMP. THE LEAK DRIPPED ONTO THE SYRINGE PUMP DURING ADMINISTRATION. THE NURSE IMMEDIATELY RETRIEVED THE NEW BIVALIRUDIN FROM THE REFRIGERATOR AND REPLACED THE MEDICATION AND MICROTUBING. THE PROVIDER WAS IMMEDIATELY NOTIFIED DUE TO FALLING PTTS. THERE WAS NO ADVERSE EVENT AND DELAY IN THERAPY THAT WOULD LEAD TO PATIENT HARM IF NOT CAUGHT BY STAFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22507919 ↗
  • MalfunctionJul 14, 2025No Flow; No Flow

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CLAVE¿ NEUTRAL CONNECTOR THAT REPORTEDLY DID NOT ALLOW FOR A SALINE PUSH THROUGH THE TUBING WITH A SALINE SYRINGE. THE ISSUE HAPPENED DURING PATIENT USE/ATTEMPT FOR ADMINISTRATION OF AN UNSPECIFIED MEDICATION. THERE WAS NO REPORT OF ANY HUMAN HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22496497 ↗
  • MalfunctionMar 26, 2025Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

    THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR WHERE THE CUSTOMER REPORTED THAT THE HUB HAS RETREATED INTO THE BLUE HUB BLOOD IS NOT STAYING DRIPPING. THE CUSTOMER STATED THAT THE NEUTRAL CONNECTOR WAS ATTACHED TO THE CONTRAST TUBING FROM THE INJECTOR AND APPEARED FINE. ONCE THE TECHNOLOGIST BEGAN THE IV INJECTION AND THERE WAS AROUND 75CC OF IV CONTRAST INJECTED, THE INJECTOR STALLED AND GAVE AN ERROR; THE CONTRAST LEAKED FROM THE ATTACHED HUB AND BOTH THE NURSE AND THE TECHNICIAN NOTICED THE WHITE PORTION IN THE INSIDE OF THE HUB RETREATED INWARDS. 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 21700154 ↗
  • MalfunctionMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR WHERE THE CUSTOMER REPORTED THAT WHEN COLLECTING BLOOD, THE HUB WAS LEAKING WITH DRAW BACKS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE NEUTRAL CONNECTOR WAS ATTACHED TO THE CONTRAST TUBING FROM THE INJECTOR AND APPEARED FINE. ONCE THE TECHNOLOGIST BEGAN THE IV INJECTION AND THERE WAS AROUND 75CC OF IV CONTRAST INJECTED, THE INJECTOR STALLED AND GAVE AN ERROR; CONTRAST LEAKED FROM THE ATTACHED HUB AND BOTH THE NURSE AND THE TECHNICIAN NOTICED THE WHITE PORTION IN THE INSIDE OF THE HUB RETREATED INWARDS. 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 21699857 ↗
  • MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT THE MORPHINE DRIP WAS LEAKING AT THE CONNECTION BETWEEN THE BLUE NAD THAT CONNECTS TO THE MEDLINE. IT WAS NOTED THAT THE MORPHINE WAS FLUSHED OUT OF THE LINE BEFORE SENDING IT. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21413958 ↗
  • MalfunctionJan 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT A CLAVE¿ NEUTRAL CONNECTOR GENERATED A LEAK DURING PATIENT USE. IT WAS REPORTED, "NAD ON PICC MEDICATION TUBING STARTED LEAKING. K+ NDER + ZOSYN POTENTIALLY LOST IN THE PROCESS. MD REQUIRED GIVING NEW DOSE OF ZOSYN TO MAKE UP FOR MISSED/LEAKING DOSE". THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21280186 ↗
  • MalfunctionDec 30, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

    THE EVENT OCCURRED ON UNSPECIFIED DATE(S) AND INVOLVED MICROCLAVE® NEUTRAL CONNECTOR. THE CUSTOMER REPORTED THAT THE DEVICE WAS LEAKING AND/OR CRACKING WHILE BEING USED. THE EVENT OCCURRED MULTIPLE DAYS FROM 21-NOV-2024. THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21044648 ↗
  • MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE MICROCLAVE® NEUTRAL CONNECTOR HAD A LEAK ISSUE. IT WAS STATED THAT THEY HAVE RECEIVED MULTIPLE REPORTS OF ITEM B3300 LEAKING AND/OR CRACKING WHILE BEING USED. THE CUSTOMER REPORTED THAT THE EVENT OCCURRED ON MULTIPLE, UNSPECIFIED DATES, STARTING 21-NOV-2024. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21035457 ↗
  • MalfunctionDec 20, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

    IT WAS REPORTED THAT THE MICROCLAVE® NEUTRAL CONNECTOR EXHIBITED A CRACK AND LEAK. THE INITIAL REPORTER STATED THAT THEY HAVE RECEIVED MULTIPLE REPORTS OF ITEM B3300 LEAKING AND/OR CRACKING WHILE BEING USED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20995848 ↗
  • MalfunctionDec 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR WHERE IT WAS REPORTED THERE WAS LEAKING FLUIDS; NEEDLESS ACCESS DEVICE (NAD) LEAKING AT CONNECTION POINT TO SYRINGE. THEY CHANGED NAD AND REPORTED ISSUE. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND UNKNOWN DELAY IN THERAPY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20905186 ↗
  • MalfunctionDec 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A MICROCLAVE® NEUTRAL CONNECTOR WHERE IT WAS REPORTED THERE WAS LEAKING AT THE CONNECTING POINT OF THE SYRINGE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20881276 ↗
  • MalfunctionDec 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT NAD LEAKING AT CONNECTION POINT TO SYRINGE. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM, AND NO SERIOUS INJURY OR DEATH OF A PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20852462 ↗
  • MalfunctionDec 4, 2024Disconnection; Fluid/Blood Leak; Separation Problem; Disconnection; Fluid/Blood Leak; Separation Problem

    THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A CLAVE¿ NEUTRAL CONNECTOR WHERE THE CUSTOMER REPORTED THAT IT WAS DIFFICULT TO THREAD AND DIFFICULT TO UNTHREAD, UNABLE TO GET THE BLUE CLAVE OFF. THE CUSTOMER STATED THAT THE PROBLEM IS USING THE BD INSYTE AUTOGUARD WITH THE ICU MEDICAL B3300. THE LEAK WAS TAKING PLACE RIGHT AT THE CONNECTION OF BOTH ONCE TWISTED TOGETHER. THE CUSTOMER ALSO STATED THAT IT IS VERY DIFFICULT TO TURN (TWIST) THE B3300 INTO THE AUTOGUARD THREADS AND ONCE IN, IT IS ALMOST IMPOSSIBLE TO REMOVE IT LIKE IT IS STUCK. THERE WAS UNKNOWN PATIENT INVOLVEMENT BUT NO ADVERSE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20848332 ↗
  • MalfunctionDec 4, 2024Fluid/Blood Leak; Separation Problem; Fluid/Blood Leak; Separation Problem

    THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A CLAVE¿ NEUTRAL CONNECTOR WHERE THE REPORTER STATED THAT THERE WAS LEAKING (BLOOD AND OR FLUIDS) AT THE CONNECTION BETWEEN THE IV CATHETER AND THE BLUE CLAVE. ADDITIONALLY, THE CUSTOMER STATED THAT THE PROBLEM WAS USING THE BD INSYTE AUTOGUARD WITH THE ICU MEDICAL B3300. THE LEAK WAS TAKING PLACE RIGHT AT THE CONNECTION OF BOTH ONCE TWISTED TOGETHER. THE CUSTOMER ALSO STATED THAT IT WAS VERY DIFFICULT TO TURN (TWIST) THE B3300 INTO THE AUTOGUARD THREADS AND ONCE IN, IT IS ALMOST IMPOSSIBLE TO REMOVE IT LIKE IT IS STUCK. THEY ARE FINDING COMPLAINTS IN CANCER CARE WITH CHEMO LEAKING. DUE TO PATIENT SAFETY, THEY CANNOT USE THE 60 CASES DUE TO THIS SERIOUS PROBLEM. THERE WAS UNKNOWN PATIENT INVOLVEMENT BUT NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20846133 ↗
  • MalfunctionDec 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A CLAVE¿ NEUTRAL CONNECTOR WHERE THE REPORTER STATED THAT THERE IS LEAKING (BLOOD AND OR FLUIDS) AT THE CONNECTION BETWEEN THE IV CATHETER AND THE BLUE CLAVE. THEY ARE FINDING COMPLAINTS IN CT SCANNER WITH CONTRAST DYE IS LEAKING. DUE TO PATIENT SAFETY, THEY CANNOT USE THE 60 CASES DUE TO THIS SERIOUS PROBLEM. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20846107 ↗

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-0692-2014 · Dec 24, 2013 · Terminated
    10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7101-001 The ICU Needleless Connector is a single use,
  • Z-0689-2014 · Dec 24, 2013 · Terminated
    6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001 The ICU Needleless Connector is a single use, sterile, non
  • Z-0694-2014 · Dec 24, 2013 · Terminated
    7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless Connector is a single use, sterile, non-pyroge
  • Z-0677-2014 · Dec 24, 2013 · Terminated
    14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, 2 Clamps, Rotating Luer, Part No. A1000, Item No. A1081 The ICU Needleless Connector is a single use, s
  • 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-0675-2014 · Dec 24, 2013 · Terminated
    87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave, 0.2 Micron Filter, 4 Clamps, Rotating Luer, 2 Exts, Drop-In NanoClave, Part No. A1000, Item No. A1078 The ICU Needl
  • 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-0700-2014 · Dec 24, 2013 · Terminated
    5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. Z3845 The ICU Needleless Connector is a single use, sterile, non-pyrogenic
  • Z-0685-2014 · Dec 24, 2013 · Terminated
    10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-0
  • Z-0658-2014 · Dec 24, 2013 · Terminated
    NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended fo
  • Z-0693-2014 · Dec 24, 2013 · Terminated
    10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7102-001 The ICU Needleless Connector is a single use,
  • Z-0667-2014 · Dec 24, 2013 · Terminated
    7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Needleless Connector is a single use, sterile
  • 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-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

…and 37 more.

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Sources and updates

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