ONE-LINK 7N8377Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00085412091808), received between Jan 15, 2018 and May 22, 2026 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET CRACKED AT THE Y SITE LUER LOCK CONNECTION, RESULTING IN LEAKAGE AND FAILURE TO DELIVER SEDATION TO PATIENT. AS A RESULT, THE PATIENT WAS REPORTEDLY UNDER SEDATED DURING THE TIME REQUIRED TO PRIME AND CONNECT A REPLACEMENT SET. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257454 ↗
• InjuryMay 22, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET CRACKED AT THE Y SITE LUER LOCK CONNECTION, RESULTING IN LEAKAGE AND FAILURE TO DELIVER SEDATION TO PATIENT. AS A RESULT, THE PATIENT WAS REPORTEDLY UNDER SEDATED DURING THE TIME REQUIRED TO PRIME AND CONNECT A REPLACEMENT SET. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257312 ↗
• MalfunctionMay 1, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT A NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET HAD A CUT IN THE TUBING. THIS WAS OBSERVED DURING PATIENT USE IN THE ICU. 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 25057511 ↗
• MalfunctionFeb 5, 2026Misconnection

  IT WAS REPORTED THAT THE CONNECTOR PLUG OF A ONE-LINK Y-TYPE STANDARD BORE CATHETER EXTENSION SET IS STUCK. THIS WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274017 ↗
• MalfunctionJun 16, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET "FELL APART" AND THE MALE ADAPTER END CAME UNATTACHED FROM THE Y SITE ADAPTER AND LEAKED. THE ISSUE OCCURRED WHEN PRIMED WITH NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213464 ↗
• InjuryApr 28, 2025Crack; Loose or Intermittent Connection; Crack; Loose or Intermittent Connection

  IT WAS REPORTED A ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET LEAKED. DURING AN UNSPECIFIED INFUSION, ¿THE THREADING AT THE PATIENT CONNECTION SITE¿ CRACKED, RESULTING IN A LOOSE CONNECTION OF THE TUBING TO THE PATIENT AND THEREFORE LEAKING MEDICATION. THE SOLUTION WAS PRESCRIBED FOR SEDATION; CONSEQUENTLY, THE SOLUTION LEAK CAUSED THE PATIENT TO BE UNDER-SEDATED, RESULTING IN TACHYCARDIA AND HYPERTENSION UNTIL THE LEAK WAS DISCOVERED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: High Blood Pressure/ Hypertension; Tachycardia

  MAUDE report 21923489 ↗
• InjuryNov 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET SEPARATED, AND THE PATIENT SUBSEQUENTLY EXPERIENCED AN AIR EMBOLISM. WHILE UNDERGOING EXTRACORPOREAL PHOTOPHERESIS THE PATIENT BEGAN COUGHING AND A SPOT OF BLOOD WAS OBSERVED ON THEIR CHEST. THE PATIENT COUGHED AGAIN, AND THE EXTENSION SET ¿CAME APART¿ AT THE CONNECTION BETWEEN THE LUER CONNECTION AND THE BIFURCATION OF THE PIGTAILS ¿DUE TO THE FORCE OF COUGHING¿. WHEN THE EXTENSION SET SEPARATED, ¿THE PORT WAS OPEN TO AIR AND WITH THE PATIENT'S COUGHING, AIR WAS DRAWN INTO THE PORT¿. THE PATIENT EXPERIENCED CHEST PAIN, SHORTNESS OF BREATH (SATURATIONS 80-82% ON 6L NASAL CANNULA), DIZZINESS, AND LIGHTHEADEDNESS. THE RAPID RESPONSE TEAM WAS CALLED TO THE PATIENT¿S ROOM AND AN EKG AND CHEST X-RAY WERE PERFORMED IMMEDIATELY. THE EXTRACORPOREAL PHOTOPHERESIS PROCEDURE WAS ABORTED, THE ONE-LINK HAD BEEN IN USE FOR 110 MINUTES. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND ADMITTED FOR OBSERVATION ON HIGH FLOW OXYGEN. A CHEST X-RAY AND CT WITHOUT CONTRAST WERE COMPLETED (PATIENT UNABLE TO UNDERGO CT WITH CONTRAST OR VQ SCAN DUE TO CONTRAST ALLERGY); HOWEVER, AIR EMBOLISM WAS DIAGNOSED ¿BASED ON THE SEQUENCE

  Patient problems: Air Embolism; Chest Pain; Dizziness; Dyspnea; Vertigo

  MAUDE report 20776501 ↗
• MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET CAME APART AT THE "Y"; THE TUBING SEPARATED FROM THE Y-JUNCTION. THIS OCCURRED PRIOR TO INTRAVENOUS PLACEMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268323 ↗
• MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET HAD A SEPARATION OF THE TUBING FROM THE Y-JUNCTION. THE EVENT WAS FURTHER DESCRIBED AS, "IV CAME APART AT THE JUNCTION OF THE PIGTAIL WHERE IT GOES FROM 1 TO 2 TUBES". 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 20267621 ↗
• MalfunctionJul 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE Y-CONNECTOR OF A ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET CAME APART AT THE GLUE/BONDED PORTION OF THE SET. THIS ISSUE WAS OBSERVED WHILE THE PATIENT WAS CONNECTED, AND THE CHEMOTHERAPY HAD JUST STARTED. 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 19822329 ↗
• MalfunctionMay 4, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET SPLIT. THIS ISSUE OCCURRED WHEN CONTRAST WAS BEING INFUSED. 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 14274260 ↗
• MalfunctionOct 23, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE LUER LOCK OF A ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET ¿CAME OFF OF LINE¿. THIS OCCURRED WHILE SETTING UP THE LINE AND ATTEMPTING TO REMOVE THE CAP ON THE BOTTOM OF THE Y-CONNECTOR. THIS WAS IDENTIFIED PRIOR TO USE ON A PATIENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10731225 ↗
• MalfunctionOct 5, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE LUER LOCK OF A ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET "CAME OFF OF LINE". 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 Consequences Or Impact To Patient

  MAUDE report 10631758 ↗
• MalfunctionAug 4, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE END CAP ON ONE END OF THE "Y" OF A ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET WAS "SEIZED" AND COULD NOT BE REMOVED. THIS 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 Consequences Or Impact To Patient

  MAUDE report 10362623 ↗
• MalfunctionJul 3, 2020Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE LUER LOCK AT THE BOTTOM OF THE Y OF A ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET WAS "SEIZED". THIS ISSUE WAS IDENTIFIED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10228330 ↗
• MalfunctionMay 26, 2020Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED 2 ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SETS WERE UNABLE TO DISCONNECT. THE ISSUE WAS FURTHER DESCRIBED AS "THE PRODUCT DOES NOT COME APART" AND IT APPEARS THE "ONE-LINK IS SEIZED TO THE Y-CONNECTOR". THIS ISSUE WAS IDENTIFIED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10088017 ↗
• MalfunctionApr 6, 2020Crack; No Flow; Crack; No Flow

  IT WAS REPORTED THAT THE DISTAL END OF TWO (2) ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SETS WERE CRACKED. IT WAS ADDITIONALLY REPORTED "THE FLUID PATH APPEARED TO BE OCCLUDED". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9931700 ↗
• MalfunctionDec 12, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET WAS LEAKING AFTER A FOLFOX TREATMENT WAS INITIATED. THE REPORTER STATED THAT THE LEAK WAS DUE TO A CRACK COMING FROM THE "Y CONNECTOR PORTION OF THE TUBING¿. THIS ISSUE WAS IDENTIFIED DURING A PATIENT INFUSION WITH AN IV (INTRAVENOUS) PUMP. AS SOON AS THE LEAK WAS IDENTIFIED, THE PUMP WAS STOPPED AND THE PATIENT WAS MOVED FROM THE AREA. THE SPILL WAS CLEANED UP WITH SPILL KIT AND DISPOSED IN CYTOTOXIC WASTE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9460381 ↗
• MalfunctionSep 14, 2018Break; Break

  IT WAS REPORTED THAT A ONE-LINK CATHETER EXTENSION SET HAD A Y-CONNECTOR DEFECT. THIS WAS OBSERVED DURING PRIMING. IT WAS FURTHER SPECIFIED THAT ¿THE PART THAT WAS SUPPOSED TO BE CONNECTED WITH LUER ON IV EXTENSION WAS BROKEN AND NOT ABLE TO BE CONNECTED AS IT WOULD NOT SLIDE¿. THE DEVICE WAS FLUSHED WITH NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7878264 ↗
• MalfunctionMay 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR WERE LEAKING. THE LEAK OCCURRED AT THE LUER LOCK END. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7520751 ↗
• MalfunctionMar 6, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT A ONE-LINK Y-TYPE CATHETER EXTENSION SET HAD A ¿BLUE CAP THAT DOES NOT SCREW.¿ THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7318060 ↗
• MalfunctionFeb 16, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT A ONE-LINK SET DID NOT PROPERLY CONNECT TO A CATHETER. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7277058 ↗
• MalfunctionJan 15, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT A ONE-LINK Y-TYPE CATHETER EXTENSION SET ¿FELL APART¿ THE REPORTER STATED THAT THE Y SITE DISCONNECTED FROM THE TUBING DURING INFUSION OF 5% DEXTROSE SOLUTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7190855 ↗

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