ONE-LINK 7N8390Recalls & reported problems
Baxter International Inc. · Non-DEHP Microbore Catheter Extension Set, Bonded Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable, Male Luer Lock Adapter with Retractable Collar · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Baxter One-Link Microbore catheter extension set is a short piece of tubing with a needle-free connector used to extend IV lines, including power injection for contrast scans. Reports mostly describe fluid or blood leaking at the connection to the patient's IV catheter, sometimes even when the connection was fully tightened, along with no flow, difficulty flushing, and lines disconnecting; a few mention air in the line. There are 53 adverse event reports, with no deaths and no injuries. 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
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00085412475417), received between Feb 12, 2018 and Sep 9, 2026 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (26 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 Leak26
- No Flow15
- Difficult to Flush11
- Disconnection3
- Air/Gas in Device1
- Detachment of Device or Device Component1
- Device Contamination with Chemical or Other Material1
- Filling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- No Consequences Or Impact To Patient6
- No Patient Involvement4
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698439 ↗MalfunctionJan 27, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A ONE LINK NON-DEHP MICROBORE CATHETER EXTENSION SET WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN AND IT WAS UNKNOWN IF A PATIENT WAS CONNECTED FOR THERAPY AT THE TIME OF THIS EVENT. 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 24192610 ↗MalfunctionDec 20, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SETS LEAKED AT THE CONNECTION TO PERIPHERAL INTRAVENOUS (PIV) CATHETERS. THIS WAS OBSERVED DURING PATIENT USE. ON OCCASION WHEN TAKING DOWN THE DRESSING, A LOOSE CONNECTION WAS OBSERVED. 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 23858744 ↗MalfunctionDec 20, 2025Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device
IT WAS REPORTED THAT A ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET HAD AIR IN THE LINE AND THEN LEAKED; THE CONNECTIONS WERE CHECKED AND THEY WERE SECURE. THE ISSUE WAS NOTICED WHILE PLACING A PERIPHERAL INTRAVENOUS (PIV) CATHETER ON A PATIENT. THE SET WAS REPLACED TO RESOLVE THE EVENT. 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 23858734 ↗MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A ONE-LINK MICROBORE CATHETER EXTENSION SET LEAKED AT THE CONNECTION SIDE. THIS WAS OBSERVED 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 22420569 ↗MalfunctionOct 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY (LESS THAN 10) OF ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SETS LEAKED SALINE AT THE CONNECTION SITE, EVEN WHEN FULLY TIGHTENED AT THE CONNECTION WITH THE PATIENT'S INTRAVENOUS CATHETER. THIS OCCURRED 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 20401093 ↗MalfunctionSep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET LEAKED AT THE CONNECTION SITE TO THE PATIENT'S INTRAVENOUS CATHETER; FURTHER DESCRIBED AS "EVEN WHEN FULLY TIGHTENED". THIS OCCURRED DURING PATIENT INFUSION. 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 20216518 ↗MalfunctionJul 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET WAS LEAKING BETWEEN THE CONNECTION SITE OF THE CATHETER TO THE IV (INTRAVENOUS) EXTENSION. THE LEAK WAS OBSERVED DURING INFUSION OF AZACITIDINE AT THE HOSPITAL. 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 19689635 ↗MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak
DURING EVALUATION OF TWO (2) RETURNED ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SETS, LEAKS WERE IDENTIFIED. THIS WAS OBSERVED DURING TESTING. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19671781 ↗MalfunctionJul 2, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED ACCESS SET LEAKED AT THE J-LOOP. THE PROCESS STEP DURING WHICH THE LEAK WAS OBSERVED WAS UNKNOWN. 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 19657592 ↗MalfunctionJun 26, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THREE (3) MICROBORE CATHETER EXTENSION SETS WITH A ONE-LINK NEEDLE-FREE IV (INTRAVENOUS) CONNECTOR WERE LEAKING FROM THE J-LOOP. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. 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 19614946 ↗MalfunctionMay 24, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A ONE-LINK MICROBORE CATHETER EXTENSION SET LEAKED. THE LEAK WAS DESCRIBED AS, "LEAKING AT J-LOOP". 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 19392523 ↗MalfunctionMay 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SETS WERE LEAKING FROM THE J LOOP. 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 19310858 ↗MalfunctionMay 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THREE (3) ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SETS WERE LEAKING AROUND THE ONE-LINK CONNECTION. THIS OCCURRED 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 19268406 ↗MalfunctionMay 2, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET LEAKED; FURTHER DESCRIBED AS "LEAKED NON-HAZARDOUS MATERIAL THROUGH THE NON-DEHP MICROBORE CATHETER EXTENSION SET". 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 19235269 ↗MalfunctionFeb 26, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT A ONE-LINK MICROBORE CATHETER EXTENSION SET LEAKED. THE LUER LOCK SEPARATED DURING SECUREMENT OF THE INTRAVENOUS (IV) SITE. AN EXTENSION SET WAS RECONNECTED 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 18778212 ↗MalfunctionDec 6, 2023Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection
IT WAS REPORTED THAT THERE WAS A DOWNSTREAM OCCLUSION ALARM ON AN UNSPECIFIED PUMP WHILE USING A ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET. WHILE ATTEMPTING TO FLUSH THE IV WITH NORMAL SALINE, IT WAS NOTED THAT THE EXTENSION SET WAS LEAKING AT THE CONNECTION TO THE IV CATHETER. WHILE RE-SECURING THE CONNECTION, THE TIP OF THE EXTENSION SET MALFUNCTIONED AND WAS FREELY MOVEABLE AND UNABLE TO FASTEN TO THE IV CATHETER SITE. TO RESOLVE THIS ISSUE, THE EXTENSION SET WAS REPLACED. 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 18279079 ↗MalfunctionNov 14, 2023Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT A SYRINGE PUMP ALARMED DURING THE USE OF A ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET. THE ALARM WAS DUE TO PRESSURE IN THE SET WHICH DELAYED THE MEDICATION DELIVERY TO THE PATIENT. 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 18136582 ↗MalfunctionOct 26, 2023Difficult to Flush; Difficult to Flush
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SETS WOULD NOT FLUSH. 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 18013097 ↗MalfunctionOct 16, 2023No Flow; No Flow
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SETS WOULD NOT FLOW; FURTHER DESCRIBED AS "WOULD NOT DRAW BLOOD THROUGH OR PUSH FLUIDS." THIS WAS IDENTIFIED DURING USE OF THE 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 17943561 ↗MalfunctionOct 5, 2023Filling Problem; Filling Problem
IT WAS REPORTED THAT TWO (2) ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SETS HAD RESTRICTED/SLOW FLOW ISSUES. THIS WAS OBSERVED DURING INJECTION OF CONTRAST AT 3.5 ML/SEC. 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 17879990 ↗MalfunctionMay 23, 2023No Flow; No Flow
IT WAS REPORTED THAT AN ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET WOULD NOT DRAW BLOOD. THIS 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 16989173 ↗MalfunctionApr 18, 2023No Flow; No Flow
IT WAS REPORTED A ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET WOULD NOT FLOW. WHILE CONNECTED TO A PATIENT, THE USER HAD "DIFFICULTY FLUSHING" AND UNABLE TO ASPIRATE BLOOD. THE EXTENSION SET WAS REPLACED. 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 16764921 ↗MalfunctionApr 18, 2023Difficult to Flush; Difficult to Flush
IT WAS REPORTED THAT AN ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET WAS ¿HARD TO FLUSH¿ DURING INFUSION. THE EXTENSION SET WAS REPLACED. 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 16763185 ↗MalfunctionApr 13, 2023Difficult to Flush; Difficult to Flush
IT WAS REPORTED THAT TWO (2) ONE-LINK MICROBORE CATHETER EXTENSION SETS WERE ¿HARD TO FLUSH¿ DURING INFUSION. THE EXTENSION SETS WERE REPLACED, AND THE OPERATOR WAS ABLE TO FLUSH THE NEW SETS WITHOUT RESISTANCE. 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 16737265 ↗
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
Other Set, administration, intravascular devices
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page