ONE-LINK 7N8371Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00085412091822), received between Jan 4, 2018 and Sep 14, 2026 — classified as 1 injury, 33 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026No Flow

  It was reported that a Non-DEHP Y-Type Microbore Catheter Extension Set exhibited no flow. The process step at which the issue occurred was not specified. There was no report of patient injury or medical intervention associated with these events. No additional information is available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758647 ↗
• MalfunctionSep 19, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT STERILE PACKAGING OF THREE (3) ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SETS WERE STAINED. THIS ISSUE WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100698 ↗
• MalfunctionJun 12, 2025Clumping in Device or Device Ingredient; No Flow; Clumping in Device or Device Ingredient; No Flow

  IT WAS REPORTED THAT THE VALVES OF FOUR (4) ONE-LINK Y-TYPE MICROBORE CATHETER EXTENSION SETS WERE CRYSTALLIZING AND WERE COMPLETELY CLOGGED. THE VALVES WERE WASHED WITH SALINE BEFORE AND AFTER ADMINISTERING MEDICATION. THIS WAS OBSERVED DURING 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 22197249 ↗
• MalfunctionJun 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET LEAKED AT THE Y-CONNECTION DURING PATIENT USE. THE SET WAS CONNECTED TO THE PATIENT'S IMPLANTED VASCULAR ACCESS DEVICE (IVAD). 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 22169064 ↗
• MalfunctionMay 16, 2025No Flow; No Flow

  IT WAS REPORTED THAT TWO (2) NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SETS DID NOT ALLOW FLUIDS TO FREELY FLOW INTO THE PATIENT'S VEIN. 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 22036851 ↗
• MalfunctionApr 23, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF TWO (2) NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SETS WAS BROKEN. THIS WAS OBSERVED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895132 ↗
• MalfunctionJan 10, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SETS HAD DISCONNECTED ONE-LINKS. THE NURSE DISCOVERED THAT THE TUBING OF ONE DEVICE DISCONNECTED DURING PATIENT INFUSION, RESULTING IN A LEAKAGE. THE NURSE ATTEMPTED TO REPLACE THE SET WITH ANOTHER DEVICE, WHEN IT WAS OBSERVED THAT THE LURE-LOCK WAS NOT CONNECTED AND FELL TO THE GROUND. 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 21131679 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET BROKE OFF. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿THE PLASTIC PIECE OF THE EXTENSION GOT CAUGHT IN THE MICROCLAVE OF THE PATIENT AND BROKE OFF¿. THIS OCCURRED DURING 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 20824508 ↗
• MalfunctionDec 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SETS HAD THE CLAVES FALLING OFF, EVEN AFTER TIGHTENING. THIS OCCURRED DURING 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 20823809 ↗
• MalfunctionOct 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET LEAKED AT THE Y-CONNECTION. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP; HOWEVER, THE SET WAS BEING USED FOR A CHEMOTHERAPY ADMINISTRATION. 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 20390592 ↗
• MalfunctionMar 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET LEAKED FROM AN UNSPECIFIED LOCATION. 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 18877467 ↗
• MalfunctionJan 27, 2023Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET LEAKED. FURTHERMORE, DURING PATIENT PLASMA INFUSION THE CONNECTION WAS NOTED TO BE "VERY LOOSE AND THE TUBING LEAKED". 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 16256999 ↗
• MalfunctionJan 27, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE DISTAL END OF AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SETS WERE BECOMING LOOSELY CONNECTED TO THE TUBING OF THE SET. THIS CONNECTION ISSUE WAS FURTHER DESCRIBED AS, ¿AN ISSUE WITH THE CONNECTION BECOMING LOOSE AT THE DISTAL END OF THE EXTENSION SET (WHERE THE LUER HUB CONNECTS TO THE TUBING)¿. THE ISSUE WAS IDENTIFIED DURING UNSPECIFIED PROCESS STEPS. 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 16253257 ↗
• MalfunctionAug 16, 2022No Flow; No Flow

  IT WAS REPORTED THAT AN ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET WAS NOT FLUSHING PROPERLY AND "WOULD TRICKLE VERY SLOWLY." THE ISSUE WAS IDENTIFIED 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 15233462 ↗
• MalfunctionAug 5, 2022No Flow; No Flow

  IT WAS REPORTED THAT AN ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET WAS NOT FLUSHING PROPERLY AND "WOULD TRICKLE VERY SLOWLY." THE ISSUE WAS IDENTIFIED 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 15176486 ↗
• MalfunctionOct 26, 2021Difficult to Flush; No Flow; Difficult to Flush; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLOW THROUGH AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SETS. THIS EVENT WAS FURTHER DESCRIBED AS, ¿COULD NOT FLUSH THEM AND IT WAS LIKE THE PLASTIC WAS PREVENTING THE FLUID FROM GOING THROUGH¿. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. 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 12695076 ↗
• MalfunctionSep 7, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT AN ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET HAD A BROKEN Y-CONNECTOR (THE TUBING SEPARATED FROM THE MALE LUER). THE ISSUE WAS IDENTIFIED 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 12434949 ↗
• MalfunctionSep 7, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING OF A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET SEPARATED FROM THE MALE LUER CONNECTOR. THIS ISSUE WAS IDENTIFIED 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 12434413 ↗
• MalfunctionSep 3, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING OF AN ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET DISCONNECTED (TUBING SEPARATED FROM THE MALE LUER). THIS ISSUE WAS IDENTIFIED 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 12423806 ↗
• MalfunctionJul 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT¿S LEFT PERIPHERAL INTRAVENOUS (IV) WAS LEAKING AT THE HUB WHERE THE ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET WAS CONNECTED. THIS WAS IDENTIFIED WHEN 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 12110763 ↗
• MalfunctionJun 30, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET CAME APART FROM THE LUER LOCK ON THE Y SITE. IT WAS FURTHER REPORTED THAT THE INTRAVENOUS (IV) LINE "SNAPPED"; FURTHER DESCRIBED AS THE WHITE LUMEN Y SITE BROKE AND RESULTED IN BLOOD COMING OUT OF THE PATIENT'S LINE. THE LINE WAS CLAMPED, CLEANED, AND THE CLAVE AND IV PRODUCTS WERE CHANGED. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. 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 12096026 ↗
• MalfunctionMay 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET WAS LEAKING CHEMOTHERAPY FROM THE VALVE. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787351 ↗
• MalfunctionMay 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET WAS LEAKING BLOOD FROM THE VALVE. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778813 ↗
• MalfunctionMay 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET WAS LEAKING NORMAL SALINE FROM THE Y-CONNECTOR. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778738 ↗
• MalfunctionNov 24, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET BROKE AND SUBSEQUENTLY LEAKED. DURING A 5FU INFUSION, THE PATIENT OBSERVED "HE IV LINE WHERE IT CONNECTED TO "Y" CONNECTOR HAD BROKEN AND BLOOD WAS COMING OUT OF THE CHEST PORT LINE". THE PATIENT CLAMPED THE PORT LINE TO STOP THE BLEEDING. THE NON-BAXTER PUMP RAN AT "1.9 ML/HOUR"; THEREFORE, "LESS THAN 4 ML CHEMOTHERAPY" LEAKED OUT. THE "Y" CONNECTOR WAS REPLACED AND THE INFUSION WAS RESTARTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10891562 ↗

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