ONE-LINK 7N8391Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00085412475400), received between Feb 12, 2018 and Sep 24, 2026 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (23 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 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026No Flow

  It was reported that there was no fluid flow through a ONE-LINK Extension Set while connected to the patient. The extension set was connected to a non Baxter catheter and a Continue flo solution set during this event. The set was primed with either Lactated Ringers or normal saline. 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 50882930 ↗
• MalfunctionApr 28, 2026Fitting Problem

  IT WAS REPORTED THAT A ONE-LINK EXTENSION SET COULD NOT BE CONNECTED TO AN ANGIOCATH. THE REPORTER STATED THAT A ULTRASOUND-GUIDED (USG) INTRAVENOUS (IV) ANGIOCATH WAS PLACED, BUT THE EXTENSION SET COULD NOT BE ATTACHED DUE TO A SMALL PIECE OF PLASTIC ON THE END OF THE EXTENSION SET. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020904 ↗
• MalfunctionMar 17, 2026Detachment of Device or Device Component

  DURING EVALUATION OF A RETURNED NON-DEHP STANDARD BORE CATHETER EXTENSION SET, A DETACHMENT OF THE TUBE AND THE MALE LUER WAS OBSERVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624082 ↗
• MalfunctionFeb 12, 2026Air/Gas in Device

  IT WAS REPORTED THAT UNSPECIFIED UNITS OF ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS HAD AIR IN LINE WHILE IN USE WITH CLEARLINK SYSTEM NON-DEHP EXTENSION SETS. THIS OCCURRED DURING 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 24324438 ↗
• MalfunctionMay 20, 2025Backflow; Break; Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging; Backflow; Break; Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING OF A ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET WAS DAMAGED. IT WAS ALSO REPORTED THAT THERE WAS A BREAK IN THE TUBING WHICH RESULTED IN A LEAK AND CAUSED BLOOD TO BACKFLOW UP THE LINE UPON CONNECTED TO INTRA VENOUS (IV). A NEW EXTENSION SET WAS USED 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 22055309 ↗
• MalfunctionOct 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS LEAKED AT THE CONNECTION TO THE INTRAVENOUS (IV) CATHETER HUB. ADDITIONALLY CLARIFIED THAT THE DEVICE LEAKED AT THE LUER CONNECTOR. 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 20517616 ↗
• MalfunctionJul 22, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE MISSING A COMPONENT. THE MISSING COMPONENT WAS DESCRIBED AS, ¿THE CLEAR, NEEDLE-FREE CONNECTOR AT THE END¿. THE SET WAS COMPLETELY OPEN ON ONE END (WITH THE IV CATHETER STILL INSIDE THE PATIENT'S HAND) AND WAS MISSING THAT CLEAR NEEDLESS ACCESS PORT. 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 19793557 ↗
• MalfunctionJul 18, 2024Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS LEAKED WHEN CONNECTED TO AN INTRAVENOUS (IV) CATHETER. THIS OCCURRED DURING PATIENT USE. THE LOCATION OF THE LEAK WAS IDENTIFIED AT THE CONNECTION POINT WHERE THE IV CATHETER MEETS THE EXTENSION SET. THE SETS WERE LEAKING WHEN CONTRAST OR MEDICATIONS WERE RUNNING THROUGH THE LINES; HOWEVER, THERE WERE NO ISSUES WHEN DRAWING BLOOD OR RUNNING SALINE. THE EVENT WAS FURTHER DESCRIBED AS, "SEEMS LIKE THEY'RE NOT SCREWING ON PROPERLY". 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 19772721 ↗
• MalfunctionJul 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF ONE-LINK STANDARD BORE CATHETER EXTENSION SETS LEAKED. IT APPEARS UNSPECIFIED T-CONNECTORS ARE ¿NOT SCREWING ON PROPERLY.¿ THE ¿IV STARTS LEAKING ALL AROUND THE SITE WHERE THE T-CONNECTOR SCREWS ON TO THE CATHETER ITSELF.¿ THE LEAKS ARE NOTED TO OCCUR DURING SOLUTION INFUSIONS OR IV PUSH 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 19757760 ↗
• MalfunctionFeb 5, 2024No Flow; No Flow

  IT WAS REPORTED THAT AN ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET HAD NO FLOW. THE EVENT WAS FURTHER DESCRIBED AS "WOULD NOT LET PULL THE BLOOD THROUGH THE EXTENSION". 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 18646481 ↗
• MalfunctionJul 7, 2023Contamination; Contamination

  IT WAS REPORTED THAT AN ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET WAS FOUND WITH A BROWN SUBSTANCE INSIDE THE TUBING. THIS WAS DISCOVERED 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 17280231 ↗
• MalfunctionOct 14, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE ENDS OF A ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET ARE DISCONNECTING. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿ET ENDS ARE BLOWING OFF WHEN THEY ARE GETTING CONTRASTED CT¿. THIS ISSUE WAS IDENTIFIED 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 15607828 ↗
• MalfunctionMay 3, 2022Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DISTAL LUER LOCK CONNECTOR OF AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS SEPARATED FROM THE TUBING. "SEVERAL" OF THESE SEPARATIONS OCCURRED DURING UNSPECIFIED PATIENT INFUSIONS AND AN UNSPECIFIED VOLUME OF BLOOD LEAKED FROM THE SITE. AFTER EACH SITUATION, THE J LOOP 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 14270365 ↗
• MalfunctionApr 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DISTAL LUER LOCK CONNECTOR OF AN ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET SEPARATED FROM THE TUBING. THE NURSE "WENT TO UNSCREW FLUSH FROM THE J LOOP AND HUB FELL OFF". THE EXTENSION SET WAS REMOVED AND 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 14253284 ↗
• MalfunctionApr 26, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE IV OF AN ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET CAME APART AT THE J-LOOP. THE ISSUE WAS IDENTIFIED 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 14213913 ↗
• MalfunctionApr 15, 2022Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS DISCONNECTED WHICH RESULTED IN A FLUID LEAK. DURING INJECTION OF INTRAVENOUS (IV) CONTRAST/SALINE, THE EXTENSION TUBING LOOSENED, AND FLUID SPILLED OUT. 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 14118675 ↗
• MalfunctionApr 15, 2022Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SET DISCONNECTED WHICH RESULTED IN A FLUID LEAK. DURING INJECTION OF INTRAVENOUS (IV) CONTRAST/SALINE, THE EXTENSION TUBING LOOSENED, AND FLUID SPILLED OUT. 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 14118660 ↗
• MalfunctionAug 12, 2021Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT TWO (2) ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE LEAKING AT THE CONNECTION SITE WITH THE HUB OF THE ANGIOCATHETERS. IT WAS FURTHER STATED THAT THE CONNECTION LOOSENS WHICH RESULTED IN AN IRON LEAK AND BLOOD LEAK BACK FROM THE ANGIOCATHETER. 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 12313118 ↗
• MalfunctionJul 21, 2021Contamination; Contamination

  IT WAS REPORTED THAT A BULK PACKAGE OF FIFTY WRAPPED ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS HAD A CONTAMINATION ISSUE. IT WAS FURTHER DESCRIBED AS A BUG HAD LAID EGGS IN THE PACKAGE THAT WRAPPED THE FIFTY EXTENSION SETS. IT WAS FURTHER STATED THAT THE PACKAGING REMAINED UNOPENED AND THE BUGS WERE SEEN THROUGH THE CLEAR WRAPPING THAT HELD THE SETS TOGETHER. THIS ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207497 ↗
• MalfunctionJun 4, 2021Disconnection; Loose or Intermittent Connection; Disconnection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE TUBING OF AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE LOOSENING AND DISCONNECTING. NO LEAKS WERE OBSERVED. THIS ISSUES WAS IDENTIFIED DURING PRIMING WITH 0.9% SODIUM CHLORIDE 10ML FLUSH PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11940044 ↗
• MalfunctionMay 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTENSION SET WITH ONE-LINK NEEDLE-FREE IV CONNECTOR WAS DEFECTIVE. THE DEFECT WAS FURTHER DESCRIBED AS A LEAK BETWEEN THE CONNECTION OF THE TUBING AND THE CONNECTOR (AT THE JUNCTION OF THE TUBING AND THE CONNECTOR). THIS ISSUE WAS IDENTIFIED WHILE IN USE ON AN ADULT PATIENT FOR AN IV (INTRAVENOUS) ANTIBIOTIC INFUSION. AS A RESULT, THE EXTENSION SET WAS REPLACED. 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 11791122 ↗
• MalfunctionApr 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK CATHETER EXTENSION SET WAS LEAKING FROM THE JUNCTION BETWEEN THE HUB AND THE LINE EXTENSION. THE LEAK WAS DISCOVERED WHILE THE PATIENT WAS CONNECTED FOR CONTRAST INJECTION. 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 11729177 ↗
• MalfunctionApr 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK CATHETER EXTENSION SET WAS LEAKING FROM THE JUNCTION BETWEEN THE HUB AND THE LINE EXTENSION. THE LEAK WAS DISCOVERED WHILE THE PATIENT WAS CONNECTED FOR CONTRAST INJECTION. 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 11729091 ↗
• MalfunctionApr 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE LEAKING FROM THE MALE LUER LOCK ADAPTER END. TO STOP THE LEAKING, THE CUSTOMER REPORTED THAT THE MALE LUER LOCK ADAPTER REQUIRED A GREAT AMOUNT OF FORCE/TWISTING. THE LEAKS WERE 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 11616370 ↗
• MalfunctionMar 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS LEAKED AROUND THE AREA WHERE THE "J-LOOP ATTACHED TO THE IV". 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 11592448 ↗

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