ONE-LINK 7N8301Recalls & reported problems
Baxter International Inc. · Non-DEHP Standard Bore Catheter Extension Set, Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable, Male Luer Lock Adapter with Retractable Collar · Class 2
Quick summary
This Baxter ONE-LINK IV extension set has 145 FDA adverse event reports, with no deaths and 5 injuries. Many describe fluid leaking at the connection, the set coming apart, or flow stopping. Some mention air entering the bloodstream, but most patients showed no clinical signs. No recalls name this device.
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
- 156
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 156 adverse event reports that list this exact device (DI 00085412475387), received between Feb 20, 2018 and Sep 30, 2026 — classified as 5 injuries, 151 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (57 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak57
- No Flow29
- Disconnection28
- Loose or Intermittent Connection10
- Backflow6
- Adverse Event Without Identified Device or Use Problem4
- Break4
- Connection Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions96
- No Consequences Or Impact To Patient37
- No Patient Involvement17
- Air Embolism4
- Decreased Respiratory Rate4
- Dyspnea4
- Tachycardia4
- Awareness During Anesthesia1
Recent adverse event reports
The 25 most recent of 156 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954831 ↗MalfunctionSep 30, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954830 ↗MalfunctionSep 28, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926068 ↗MalfunctionSep 28, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926028 ↗MalfunctionSep 28, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925974 ↗MalfunctionSep 28, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925968 ↗MalfunctionSep 28, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925967 ↗MalfunctionSep 28, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923571 ↗MalfunctionSep 15, 2026Backflow; Fracture
It was reported that a Non-DEHP Standard Bore Catheter Extension Set exhibited a crack on its luer lock adapter. This occurred during use while connected to the patient. The reporter stated that the luer connection point did not slide properly due to the broken component, resulting is blood backflow. No blood loss was reported. 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 50773253 ↗MalfunctionSep 11, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740555 ↗MalfunctionSep 11, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739907 ↗MalfunctionSep 11, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738399 ↗MalfunctionSep 11, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738382 ↗MalfunctionSep 11, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738068 ↗MalfunctionAug 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379870 ↗MalfunctionAug 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379752 ↗MalfunctionAug 4, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130318 ↗MalfunctionAug 3, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50124056 ↗MalfunctionAug 3, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50123409 ↗MalfunctionApr 29, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP STANDARD BORE CATHETER EXTENSION SET LEAKED AT THE CONNECTION SITE. AN EMERGENCY DEPARTMENT REGISTERED NURSE STARTED AN IV ON THE PATIENT AND A "J LOOP" (EXTENSION SET) WAS CONNECTED CORRECTLY AND TIGHTENED; HOWEVER, BLOOD LEAKED FROM THE CONNECTION ONTO THE PATIENT AND BED. WHEN THE NURSE ATTEMPTED TO FLUSH THE IV, FLUID CONTINUED TO DRIP FROM THE CONNECTION SITE. 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 25037717 ↗MalfunctionApr 24, 2026Fluid/Blood Leak; Loose or Intermittent Connection
IT WAS REPORTED THAT TWO (2) ONE LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS HAD A LOOSE HUB/CAP DURING USE, RESULTING IN BLOOD FILLING THE TUBING AND LEAKAGE AT THE INTERFACE BETWEEN THE TUBING AND THE CAP. 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 24988652 ↗MalfunctionMar 16, 2026Difficult to Flush
IT WAS REPORTED THAT TWO (2) NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WOULD NOT FLUSH DURING PATIENT USE. PATIENT BLOOD WAS ABLE TO BE DRAWN THROUGH THE SETS; HOWEVER, WHEN ATTEMPTING TO FLUSH, THE DEVICES WOULD NOT FLUSH. NEW SETS WERE OBTAINED TO CONTINUE TREATMENT. 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 24611806 ↗MalfunctionMar 11, 2026Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT A ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET BECAME DISCONNECTED AT THE HUB OF THE INTRAVENOUS PLACED IN THE PATIENT'S RIGHT ANTECUBITAL AREA. NO ISSUE WAS OBSERVED WHEN THE LINE WAS FLUSHED WITH NORMAL SALINE; HOWEVER, THE DISCONNECTION OCCURRED AFTER IV CONTRAST WAS INITIATED. 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 24575474 ↗MalfunctionMar 2, 2026Disconnection
IT WAS REPORTED THAT AN ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET WAS DISCONNECTED FROM THE MALE LUER LOCK ADAPTER AT SITE OF CONNECTION. THIS OCCURRED PRIOR TO PROCEDURE AT PRE OPERATIVE DEPARTMENT. 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 24488730 ↗MalfunctionFeb 25, 2026Mechanical Jam
IT WAS REPORTED THAT THE MALE LUER OF AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE GETTING STUCK. THE ISSUE 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 24445385 ↗
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 · TerminatedBaxter 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 · TerminatedONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.