ONE-LINK 7N8399Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 00085412091785), received between Oct 10, 2017 and Aug 19, 2026 — classified as 2 injuries, 118 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K132734); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325520 ↗
• MalfunctionMay 6, 2026No Flow

  IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH A ONE-LINK NEEDLE FREE IV CONNECTOR. A BRAND-NEW CLEAR NEEDLELESS CONNECTOR (BAXTER ONE LINK NEEDLE FREE IV CONNECTOR) DID NOT FUNCTION PROPERLY WHEN REMOVED FROM ITS PACKAGING. THE CONNECTOR WAS ATTACHED TO A NEW MIDLINE CATHETER TO ASSESS BLOOD RETURN AND FLUSHING. WITH THIS CONNECTOR IN PLACE, THE LINE FLUSHED WITHOUT ISSUE BUT DID NOT PRODUCE A BLOOD RETURN. THE CONNECTOR WAS THEN REMOVED, AND THE NEW MIDLINE CATHETER WAS TESTED WITHOUT A CONNECTOR; IT FUNCTIONED AS EXPECTED, WITH SUCCESSFUL BLOOD ASPIRATION AND FLUSHING. A SECOND NEW BAXTER CONNECTOR WAS SUBSEQUENTLY ATTACHED, AND THE LINE AGAIN FUNCTIONED NORMALLY, DEMONSTRATING BOTH BLOOD RETURN AND ADEQUATE FLUSHING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107209 ↗
• MalfunctionMar 19, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) NEEDLE-FREE IV CONNECTORS CRACKED WHILE DRAWING BLOOD FOR LABS FROM A SLEEPING PATIENT. WHILE THE CONNECTOR WAS ATTACHED TO THE PATIENT, THE NURSE NOTICED LARGE BUBBLES IN "LINE AND DRAWING TUBE FILLED WITH BUBBLES"; A BLOOD LEAK WAS OBSERVED. THE LINE AND CONNECTOR WAS REMOVED AND CHANGED. WHEN DRAWING FROM THE CONNECTOR (CAP) CLOSEST TO THE HUB, BUBBLING CONTINUED. THE BUBBLING STOPPED AFTER CHANGING THE NEEDLE-FREE IV CONNECTOR AND LINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640971 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ONE-LINK NEEDLE-FREE IV CONNECTORS BROKE APART. IT WAS OBSERVED THAT WHEN USING SKIN ADHESIVE, THE SECURE PORT SKIN ADHESIVE TOUCHES THE ONE-LINK AND THE NEEDLE FREE CONNECTOR BREAK IN HALF AND COMES APART. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365512 ↗
• MalfunctionFeb 3, 2026Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT AN ONE-LINK NEEDLE-FREE IV CONNECTOR CAME APART FROM AN UNSPECIFIED TUBING. THIS OCCURRED DURING COMPUTED TOMOGRAPHY (CT) CONTRAST INJECTION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248078 ↗
• MalfunctionFeb 3, 2026Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT AN ONE-LINK NEEDLE-FREE IV CONNECTOR CAME APART FROM AN UNSPECIFIED EXTENSION TUBING. THIS OCCURRED DURING COMPUTED TOMOGRAPHY (CT) CONTRAST INJECTION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245501 ↗
• MalfunctionNov 11, 2025Backflow; Backflow

  IT WAS REPORTED THAT THREE (3) ONE-LINK NEEDLE-FREE IV CONNECTORS HAD FLOW ISSUES WITH THEIR INJECTORS, RESULTING IN CONTRAST BACKUP DURING SCANS. IOHEXOL CONTRAST WAS BACKFLOWING ON THREE PATIENTS (CT AND ER PATIENTS). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524282 ↗
• MalfunctionOct 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A ONE-LINK NEEDLE-FREE IV CONNECTOR CAME APART BELOW THE STOPCOCK AND IV CONNECTOR. THIS WAS OBSERVED DURING USE. THIS WAS USED IN CONJUNCTION WITH PURPLE LUMEN. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441832 ↗
• MalfunctionOct 22, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT A ONE-LINK NEEDLE-FREE IV CONNECTOR DISCONNECTED FROM THE T-CONNECTOR. THIS WAS OBSERVED DURING PATIENT INFUSION WHEN THE PUMP WAS BEING PROGRAMMED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23362461 ↗
• MalfunctionAug 11, 2025Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE PACKAGING OF AN UNSPECIFIED QUANTITY OF ONE-LINK NEEDLE-FREE IV CONNECTORS BECAME WET / DAMP (SANITIZER, WATER FROM HAND WASHING) AND THE INFORMATION (BLUE WRITING) ON THE BACK WIPES OFF. THIS WAS NOTICED BEFORE PATIENT USE IN THE SURGICAL INTENSIVE CARE UNIT. THE CONCERN WAS FOR REMOVAL OF INFORMATION RELATED TO PRESSURE, TOLERANCE FOR INJECTION PURPOSES, OR VOLUME REQUIRED REQUIREMENTS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773353 ↗
• MalfunctionAug 8, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A ONE-LINK NEEDLE-FREE IV CONNECTOR SEPARATED WHICH RESULTED IN A FLUID LEAK. THE CONNECTOR SEPARATED UNDER PRESSURE WHILE FLUSHING A PICC LINE WITH SALINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754567 ↗
• MalfunctionJul 8, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NEEDLE-FREE IV CONNECTORS HAD A DAMAGED OVERPOUCH. THIS WAS OBSERVED BEFORE PRODUCT USE. THE EVENT WAS FURTHER DESCRIBED AS "PEEL PACK PAPER ON THE FRONT OF THE PRODUCT IS VERY THIN AND FRAGILE CAUSING IT TO BREAK OFF AND CRUMPLE. LOOKS LIKE A HARD BOILED EGG." THE PACKAGING LOOKED AS IF IT WAS "MISSING THE MEMBRANE THAT GOES ON THE BACK SIDE OF THE FRONT COVER CAUSING IT TO DISINTEGRATE". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22445277 ↗
• MalfunctionJun 13, 2025Crack; Crack

  IT WAS REPORTED THAT A ONE-LINK NEEDLE-FREE IV CONNECTOR CRACKED IN HALF DURING USE. THE ISSUE WAS NOTICED WHILE INFUSING UNSPECIFIED FLUIDS AT 5 ML/H WITH AN UNSPECIFIED INFUSION PUMP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207029 ↗
• MalfunctionMay 19, 2025No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH A ONE-LINK NEEDLE-FREE IV CONNECTOR. WHILE FLUSHING THE INTRAVENOUS (IV) TUBING, IT WAS OBSERVED THAT THERE WAS RESISTANCE, AND NOTHING COULD BE FLUSHED THROUGH THE IV. TO RESOLVE THIS ISSUE, THE ONE-LINK CONNECTOR WAS REPLACED AND THE FLUSH WORKED FLAWLESSLY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044463 ↗
• MalfunctionApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK NEEDLE-FREE IV CONNECTOR LEAKED FROM AN UNSPECIFIED LOCATION. THE DEVICE CONTAINED IV (INTRAVENOUS) SOLUTION. THE DEVICE WAS REPLACED WITH A NEW DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930766 ↗
• MalfunctionNov 15, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF ONE-LINK NEEDLE-FREE IV CONNECTORS DISCONNECTED. THE SETS ARE USED TO INFUSE ONCOLOGY MEDICATIONS. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698348 ↗
• MalfunctionOct 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKS WERE OBSERVED DURING USE OF AN UNSPECIFIED QUANTITY OF ONE-LINK NEEDLE-FREE IV CONNECTORS. THIS OCCURRED WHILE USING THE DEVICES WITH CHEMOTHERAPY MEDICATION; HOWEVER, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20487361 ↗
• MalfunctionOct 9, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PRIMARY PACKAGING OF A ONE-LINK NEEDLE-FREE IV CONNECTOR WAS CRACKED AND "ALMOST BRITTLE TO TOUCH". THIS WAS OBSERVED WHEN THE NURSE PULLED THE PRODUCT TO OPEN THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20411381 ↗
• MalfunctionAug 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK NEEDLE-FREE IV CONNECTOR LEAKED FROM THE CAP. PRIOR TO STARTING A BLOOD TRANSFUSION ON A PATIENT, THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) CAP AND LINE CONNECTIONS WERE CHECKED TO MAKE SURE THEY WERE TIGHTENED. AFTER BLOOD WAS INITIATED, THERE WAS A SMALL AMOUNT OF BLOOD WAS NOTED ON THE SHEETS WHICH APPEARED TO COME FROM THE CAP THAT WAS CONNECTED TO THE PICC LINE. THE TRANSFUSION WAS PAUSED SO THE NURSE COULD CHECK AND CONFIRM THAT THE CAP WAS ON TIGHT. THE AREA AROUND THE CAP WAS CLEANED WITH AN ALCOHOL SWAB. HOLDING A NEW ALCOHOL SWAB UNDER THE CONNECTION, THE NURSE RESTARTED THE TRANSFUSION AND NOTED THAT SMALL LEAK OF BLOOD CONTINUED FROM THE TIGHTENED CAP. TRANSFUSION PAUSED AND DISCONNECTED, CAP CHANGED, AND TRANSFUSION CONTINUED THROUGH NEW CAP WITHOUT ISSUES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072878 ↗
• MalfunctionAug 18, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED CLOTTING WAS NOTED IN UNSPECIFIED BAXTER CATHETERS, WHEN USED IN CONJUNCTION WITH AN UNSPECIFIED QUANTITY OF ONE-LINK NEEDLE-FREE IV CONNECTORS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999362 ↗
• MalfunctionJul 1, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT A ONE-LINK NEEDLE-FREE IV CONNECTOR DISCONNECTED FROM THE CENTRAL LINE; FURTHER DESCRIBED AS THE "STOPCOCK". THIS WAS OBSERVED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651545 ↗
• MalfunctionJun 17, 2024Obstruction of Flow; No Flow; Obstruction of Flow; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH TWO (2) ONE-LINK NEEDLE-FREE IV CONNECTORS. MEDICATION WAS NOT PASSING THROUGH THE DEVICES AND FAILED DUE TO OCCLUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547765 ↗
• MalfunctionJun 13, 2024No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH THREE (3) ONE-LINK NEEDLE-FREE IV CONNECTORS. IT WAS OBSERVED THE SETS DID NOT WORK WITH GRAVITY DRIP. THESE ISSUES OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531864 ↗
• MalfunctionJun 13, 2024No Flow; No Flow

  IT WAS REPORTED THAT TWO (2) ONE-LINK NEUTRAL LUER ACTIVATED DEVICE WOULD NOT FLOW. THE DEVICE WAS ABLE TO FLUSH WITH ABOUT 1 ML OF NORMAL SALINE, BUT THEN WAS NOT ABLE TO FLUSH OR ASPIRATE. THE "LINE WAS VERIFIED TO BE IN THE VESSEL." THE SET WAS CHANGED AND FLOWED WITHOUT ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531403 ↗
• MalfunctionJun 13, 2024No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH THREE (3) ONE-LINK NEEDLE-FREE IV CONNECTORS. IT WAS OBSERVED THAT NO INTRAVENOUS FLUID PASSED UNDER GRAVITY AND FLUID WOULD FLOW ONLY IF "PUSHED" WITH A SYRINGE OR INFUSION PUMP. THIS WAS OBSERVED AT THE TIME OF CANNULATION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531256 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132734. One submission often covers many models, so check the product and lot details in each record.

• Z-1102-2021 · Dec 21, 2020 · Terminated
  Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended
• Z-0132-2016 · May 21, 2015 · Terminated
  ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT