ONE-LINK 7N8332KRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00085412599625), received between Mar 10, 2023 and May 29, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “No Flow” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Crack; Crack

  IT WAS REPORTED THAT THE HUB OF A ONE-LINK 3 LEAD MICROBORE CATHETER EXTENSION SET WAS CRACKED. THE TUBING HEAD WAS ALSO CRACKED. THIS WAS OBSERVED DURING SETUP. 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 22110360 ↗
• MalfunctionApr 25, 2025Obstruction of Flow; Air/Gas in Device; Obstruction of Flow; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ONE-LINK NON-DEHP 3 LEAD MICROBORE CATHETER EXTENSION SETS HAD AIR ENTERING THE LINES; FURTHER DESCRIBED AS "INTERRUPTED LINES". THIS WAS OBSERVED DURING PATIENT USE IN THE NEONATAL INTENSIVE CARE UNIT (NICU). ADDITIONALLY, THE EVENT WAS FURTHER DESCRIBED AS DEVICES NOT HAVING "NEGATIVE PRESSURE" WHICH RESULTED IN THE LINES BACKING UP; IF THE TO KEEP OPEN (TKO) PRESSURE WAS NOT HIGH ENOUGH, THERE WAS CLOTTING AS WELL. THE CUSTOMER WAS WORKING WITH STAFF TO ENSURE PROPER TIGHTENING OF THE CONNECTION TO THE INTRAVENOUS (IV) TUBING. 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 21913662 ↗
• MalfunctionApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A ONE-LINK NON-DEHP 3 LEAD MICROBORE CATHETER EXTENSION SET HAD A SEPARATION BETWEEN THE TUBING AND THE MALE LUER LOCK ADAPTER. THIS OCCURRED WHILE PATIENT WAS CONNECTED TO 3 UNSPECIFIED CONTINUOUS INFUSIONS. 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 21893849 ↗
• MalfunctionMar 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) ONE-LINK 3 LEAD MICROBORE CATHETER EXTENSION SETS LEAKED FROM AN UNSPECIFIED LOCATION. 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 21720373 ↗
• MalfunctionMar 13, 2023No Flow; No Flow

  IT WAS REPORTED THAT THE PORT (CONNECTOR) OF AN ONE-LINK NON-DEHP 3 LEAD MICROBORE CATHETER EXTENSION SET WAS OCCLUDED. THE EVENT 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 16530356 ↗
• MalfunctionMar 10, 2023No Flow; No Flow

  IT WAS REPORTED THAT THE PORT OF THE TRIFUSE OF TWO (2) ONE-LINK NON-DEHP 3 LEAD MICROBORE CATHETER EXTENSION SETS WERE OCCLUDED. 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 16522344 ↗

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