ONE-LINK 7N8378Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00085412091792), received between Jan 16, 2018 and Sep 25, 2026 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Rupture

  It was reported that five (5) Non-DEHP Standard Bore Catheter Extension Sets fractured during infusion of intravenous contrast for computed tomography (CT) scans. 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 50900318 ↗
• MalfunctionSep 10, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722379 ↗
• MalfunctionMay 15, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AT LEAST TWO ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS SPLIT OPEN AND RESULTED IN LEAK DURING IV CONTRAST INJECTION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 25192607 ↗
• MalfunctionMay 15, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A ONE LINK NON DEHP STANDARD BORE CATHETER EXTENSION SET SPLIT OPEN BEFORE THE BONDED CONNECTOR AND LEAKED. THIS OCCURRED WHILE FLUSHING A NEWLY PLACED INTRAVENOUS (IV). 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 25186766 ↗
• MalfunctionMay 14, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP STANDARD BORE CATHETER EXTENSION SETS "SPLIT OPEN", RESULTING IN LEAKS. THE EVENTS OCCURRED DURING 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 25176284 ↗
• MalfunctionJan 2, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET WAS SEVERED AND BROKE AT THE CONNECTION SITE. THE LINE WAS PRE PRIMED WITH RINGERS LACTATE SOLUTION BEFORE CONNECTION TO PATIENT. THE SET WAS REPLACED TO RESOLVE THE 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 23950820 ↗
• MalfunctionDec 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUBING OF TWO (02) ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS RUPTURED. THIS OCCURRED DURING COMPUTED TOMOGRAPHY WITH INTRAVENOUS (IV) CONTRAST 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 23934204 ↗
• MalfunctionDec 18, 2025Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS SPLIT WHILE USING A POWER INJECTOR. THE FIRST EXTENSION SET BLEW OUT DURING ADMINISTRATION OF INTRAVENOUS CONTRAST IN CT. A NEW EXTENSION SET WAS SET UP; HOWEVER, WHEN CONTRAST WAS ADMINISTERED, THE EXTENSION SET RUPTURED. THE INTRAVENOUS CONTRAST LEAKED AND THE QUANTITY OF LEAKING SETS 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 23843064 ↗
• MalfunctionDec 3, 2025Material Rupture

  DURING CT WITH IV CONTRAST ADMINISTRATION (NOT A HIGH-PRESSURE ADMINISTRATION) 2 DIFFERENT IV EXTENSION SET TUBES RUPTURED. BOTH EXTENSIONS WERE FROM THE SAME LOT NUMBER. THE STAFF ARE REMOVING THIS LOT NUMBER FROM THE STOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704580 ↗
• MalfunctionDec 1, 2025Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A ONE-LINK STANDARD BORE CATHETER EXTENSION SET DID NOT PROPERLY ENGAGE WITH THE PERIPHERAL VENOUS CATHETER AND LEAKED FROM AN UNSPECIFIED LOCATION DURING AN ATTEMPT TO ESTABLISH PATENCY. THIS WAS OBSERVED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687337 ↗
• MalfunctionNov 18, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET, WHICH WAS CONNECTED TO A INTRAVENOUS CATHETER, WAS CRACKED RESULTING IN A FLUID LEAK. DURING ADMINISTRATION, IT WAS OBSERVED THAT CONTRAST/SALINE WAS LEAKING FROM THE CRACK IN THE SET. 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 23588026 ↗
• MalfunctionNov 18, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET, WHICH WAS CONNECTED TO A INTRAVENOUS CATHETER, WAS CRACKED RESULTING IN A FLUID LEAK. DURING ADMINISTRATION, IT WAS OBSERVED THAT CONTRAST/SALINE WAS LEAKING FROM THE CRACK IN THE SET. 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 23587489 ↗
• MalfunctionNov 18, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET, WHICH WAS CONNECTED TO A INTRAVENOUS CATHETER, WAS CRACKED RESULTING IN A FLUID LEAK. DURING ADMINISTRATION, IT WAS OBSERVED THAT CONTRAST/SALINE WAS LEAKING FROM THE CRACK IN THE SET. 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 23587484 ↗
• MalfunctionAug 8, 2025Unsealed Device Packaging; Material Split, Cut or Torn; Unsealed Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET HAD A UNIFORM CUT. THE ISSUE WAS FURTHER DESCRIBED AS; "THE TUBING WAS INCOMPLETE WITH A UNIFORM CUT". THE TUBING WAS OUTSIDE OF THE PRIMARY PACKAGING, DESPITE BEING HERMETICALLY SEALED. THIS WAS DISCOVERED DURING DISPENSING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22747930 ↗
• MalfunctionJul 15, 2025Backflow; Backflow

  IT WAS REPORTED THAT A ONE-LINK STANDARD BORE CATHETER EXTENSION SET HAD BLOOD BACKFLOW. THIS WAS OBSERVED 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 22513865 ↗
• MalfunctionJan 7, 2025Material Rupture; No Flow; Material Rupture; No Flow

  IT WAS REPORTED THAT THE TUBING OF TWO (2) ONE-LINK STANDARD BORE CATHETER EXTENSION SETS RUPTURED APPROXIMATELY AN INCH FROM THE LOCK FROM FLOW ISSUES. THIS WAS OBSERVED DURING A CT (COMPUTED TOMOGRAPHY) PE (PULMONARY EMBOLISM) STUDY. THE TUBING WAS USED WITH A CT, AND THERE WAS NO FLOW OF FLUID. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21097676 ↗
• MalfunctionFeb 14, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT AN ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET LEAKED. THE DEVICE DISCONNECTED FROM A CATHETER RESULTING IN SPILLAGE OF SALINE SOLUTION. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707677 ↗
• MalfunctionNov 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUBING OF A ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET RUPTURED DURING ADMINISTRATION OF INTRAVENOUS (IV) CONTRAST. 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 18179249 ↗
• MalfunctionNov 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUBING OF AN ONE-LINK STANDARD BORE CATHETER EXTENSION SET RUPTURED DURING THE ADMINISTRATION OF INTRAVENOUS (IV) CONTRAST. 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 18161055 ↗
• MalfunctionNov 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUBING OF AN ONE-LINK STANDARD BORE CATHETER EXTENSION SET RUPTURED DURING THE ADMINISTRATION OF INTRAVENOUS (IV) CONTRAST. 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 18160872 ↗
• MalfunctionDec 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET LEAKED. THIS WAS OBSERVED DURING PATIENT USE. THE LEAK WAS NOTED ON THE SIDE OF THE TUBING. 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 13113981 ↗
• MalfunctionJun 24, 2021Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THE "J LOOP" SPLIT ON A ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET AND SUBSEQUENTLY LEAKED. THIS ISSUE OCCURRED DURING CONTRAST INJECTION OF 1.5ML/SEC USING AN UNSPECIFIED POWER INJECTOR WITH 300 PSI. IT WAS FURTHER REPORTED THAT THE INJECTION WAS NOT PRESSURE LIMITED. 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 12058303 ↗
• MalfunctionJun 24, 2021Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THE "J LOOP" SPLIT ON A ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET AND SUBSEQUENTLY LEAKED. THIS ISSUE OCCURRED DURING CONTRAST INJECTION OF 1.5ML/SEC USING AN UNSPECIFIED POWER INJECTOR WITH 300 PSI. IT WAS FURTHER REPORTED THAT THE INJECTION WAS NOT PRESSURE LIMITED. 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 12058294 ↗
• MalfunctionMay 28, 2021Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET SPLIT OPEN AND LEAKED. IT WAS FURTHER REPORTED THAT THE DISTAL END OF TUBING BULGED AND SPLIT OPEN WHEN POWER INJECTOR WAS FLUSHING WITH SALINE. THE DEVICE HAD BEEN IN USE FOR FIVE (5) MINUTES WHEN THE ISSUE OCCURRED. THERE WAS NO DIRECT CONTACT OR EXPOSURE AND 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 11902156 ↗
• MalfunctionApr 5, 2021Packaging Problem; Material Split, Cut or Torn; Packaging Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO (2) ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS HAD STERILE PACKAGING ISSUES. DURING SETUP/PREPARATION, IT WAS DISCOVERED THE TWO SETS WERE RECEIVED CONJOINED. THIS ISSUE WAS FURTHER DESCRIBED AS HALF OF ONE SET WAS PROTRUDING OUTSIDE OF ITS STERILE PACKAGING AND WAS WITHIN THE PACKAGING OF THE SECOND SET. THE TUBING OF THE SET THAT WAS BETWEEN THE TWO PACKAGES WAS ALSO CUT. THIS EVENT WAS IDENTIFIED DURING SETUP/PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617016 ↗

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