ONE-LINK 7N8300Recalls & reported problems
Baxter International Inc. · Non-DEHP Microbore Catheter Extension Set, Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable, Male Luer Lock Adapter with Retractable Collar · Class 2
Quick summary
This Baxter ONE-LINK catheter extension set, a short tube used to connect intravenous lines, has 116 adverse event reports on file. Many describe the connector coming loose during infusion, and many describe fluid or blood leaking or no fluid flowing. The reports include no deaths and no injuries, and the number of reports rose from 10 to 26 over the last 12 months. 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
- 120
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 00085412091839), received between Jan 12, 2018 and Sep 28, 2026 — classified as 120 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (44 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 Leak44
- No Flow34
- Disconnection29
- Tear, Rip or Hole in Device Packaging6
- Detachment of Device or Device Component4
- Loose or Intermittent Connection4
- Crack3
- Failure to Prime2
Patient problems
- No Clinical Signs, Symptoms or Conditions72
- No Consequences Or Impact To Patient34
- No Patient Involvement13
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926069 ↗MalfunctionSep 15, 2026Fluid/Blood Leak; Loose or Intermittent Connection
It was reported that a One-Link Non-DEHP Microbore Catheter Extension Set leaked at the intravenous connection during patient infusion of atezolizumab. The connector was reported to be securely connected prior to infusion; however, the connector became loose during use. The infusion was stopped and the line was reassessed and secured 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 50766655 ↗MalfunctionSep 15, 2026Fluid/Blood Leak; Fitting Problem
It was reported that a One-Link Non-DEHP Microbore Catheter Extension Set could not be attached to an intravenous catheter and leaked when flushed with Sodium Chloride. This occurred during preparation and flushing prior to intravenous catheter insertion. There was no patient involvement. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766361 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718162 ↗MalfunctionSep 10, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715565 ↗MalfunctionSep 10, 2026Fitting Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50705285 ↗MalfunctionAug 26, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50464423 ↗MalfunctionAug 26, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50457885 ↗MalfunctionAug 25, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441431 ↗MalfunctionJun 12, 2026
CATHETER EXTENSION SET SEPARATES INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25485183 ↗MalfunctionMay 27, 2026Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ONE-LINK CONNECTOR OF A ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET CAME LOOSE DURING PATIENT INFUSION RESULTING IN BLOOD LEAK. 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 25311498 ↗MalfunctionMay 21, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE ONE LINK CONNECTOR OF TWO (2) ONE LINK NON DEHP MICROBORE CATHETER EXTENSION SETS LOOSENED AND CAME OFF DURING INFUSION. THE EVENT OCCURRED IN NICU. 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 25241425 ↗MalfunctionMay 15, 2026Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT A NON DEHP MICROBORE CATHETER EXTENSION SET SEPARATED AT THE CONNECTION BETWEEN THE CAP AND THE TUBING, RESULTING IN THE IV CATHETER BEING LEFT OPEN TO AIR, AND SUBSEQUENT BLOOD LEAK FROM A NEONATAL PATIENT. THE EVENT WAS IDENTIFIED IN THE NICU DURING AN INFUSION AFTER APPROXIMATELY 24 HOURS OF 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 25189981 ↗MalfunctionApr 21, 2026Failure to Prime
IT WAS REPORTED THAT A NON-DEHP MICROBORE CATHETER EXTENSION SET DID NOT ALLOW SALINE TO FLUSH THROUGH THE LINE. THE EVENT OCCURRED DURING PRIMING IN THE PEDIATRIC EMERGENCY DEPARTMENT PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24945313 ↗MalfunctionApr 2, 2026Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON DEHP MICROBORE CATHETER EXTENSION SETS DISCONNECTED AND LEAKED AT THE CATHETER HUB. THE HUB CONNECTING TO THE PATIENT SIDE IV WAS DESCRIBED AS SLIGHTLY OVERSIZED AND ASSOCIATED WITH LEAKAGE. INSTANCES OF LEAKAGE WITH MINIMAL BLOOD LOSS WERE REPORTED. IN MOST CASES, THE LEAKS WERE PROMPTLY IDENTIFIED DURING FLUSHING WITH 0.9% SODIUM CHLORIDE. 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 24770666 ↗MalfunctionApr 2, 2026Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON DEHP MICROBORE CATHETER EXTENSION SETS DISCONNECTED AND LEAKED AT THE CATHETER HUB. THE HUB CONNECTING TO THE PATIENT SIDE IV WAS DESCRIBED AS SLIGHTLY OVERSIZED AND ASSOCIATED WITH LEAKAGE. INSTANCES OF LEAKAGE WITH MINIMAL BLOOD LOSS WERE REPORTED. IN MOST CASES, THE LEAKS WERE PROMPTLY IDENTIFIED DURING FLUSHING WITH 0.9% SODIUM CHLORIDE. 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 24769743 ↗MalfunctionApr 1, 2026Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP MICROBORE CATHETER EXTENSION SET HAD A CONNECTION ISSUE AND LEAKED AT THE CATHETER HUB. THE CUSTOMER REPORTED THAT THE HUB THAT CONNECTS TO THE PATIENT SIDE OF THE IV IS ¿SLIGHTLY LARGER¿ AND HAD A LEAK. 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 24757999 ↗MalfunctionApr 1, 2026Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP MICROBORE CATHETER EXTENSION SET HAD A CONNECTION ISSUE AND LEAKED AT THE CATHETER HUB. THE CUSTOMER REPORTED THAT THE HUB THAT CONNECTS TO THE PATIENT SIDE OF THE IV IS ¿SLIGHTLY LARGER¿ AND HAD A LEAK. 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 24757765 ↗MalfunctionMar 31, 2026Defective Component; No Flow
IT WAS REPORTED THAT THERE WAS AN INABILITY TO FLUSH OR DRAW BLOOD DURING USE OF A NON-DEHP MICROBORE CATHETER EXTENSION SET. THIS OCCURRED DURING PERIPHERAL INTRAVENOUS LINE (PIV) INSERTION. WHEN THE EXTENSION SET WAS REMOVED TO TRY AND FLUSH, THE ADAPTER ON THE DEVICE WAS FOUND TO BE DEFECTIVE (NOT FURTHER SPECIFIED). A NEW CATHETER EXTENSION WAS PLACED. 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 24746719 ↗MalfunctionMar 12, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP MICROBORE CATHETER EXTENSION SET LEAKED WHERE BETWEEN THE SOFT TUBING AND THE HARD CONNECTOR (FEMALE LUER LOCK) WHERE THE "MICROCLAVE" (ONE-LINK) IS ATTACHED. 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 24584463 ↗MalfunctionMar 12, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP MICROBORE CATHETER EXTENSION SETS LEAKED WHERE BETWEEN THE SOFT TUBING AND THE HARD CONNECTOR (FEMALE LUER LOCK) WHERE THE "MICROCLAVE" (ONE-LINK) IS ATTACHED. 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 24583669 ↗MalfunctionMar 2, 2026
DURING PIV [PERIPHERAL INTRAVENOUS LINE] INSERTION THE CATHETER EXTENSION SET WAS FOUND DEFECTIVE. UNABLE TO FLUSH OR DRAW BLOOD FROM IT. ALMOST PULLED IV OUT THINKING IT HIT A VALVE WHEN I DECIDED TO REMOVE EXTENSION AND TRY TO FLUSH. THAT'S WHEN OBSERVED THAT THE ADAPTER ON THE DEVICE IS DEFECTIVE. NEW CATHETER EXTENSION PLACED. PRODUCT BAXTER ONE-LINK NON-DEPH MICROBORE CATHETER EXTENSION SET (B)(4), LOT (10) UR25F040245
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24477514 ↗MalfunctionJan 26, 2026No Flow
IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF ONE-LINK MICROBORE CATHETER EXTENSION SETS COULD NOT FLUSH SALINE THROUGH THE LINE. THIS WAS OBSERVED 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 24184471 ↗MalfunctionJan 12, 2026Failure to Infuse
IT WAS REPORTED THAT EIGHT (8) ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SETS WERE NOT DRAWING FLUID AS INTENDED. 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 24046237 ↗MalfunctionJan 9, 2026Fluid/Blood Leak
IT WAS REPORTED THAT (B)(4) ONE-LINK MICROBORE CATHETER EXTENSION SETS LEAKED FROM THE HUB THAT CONNECTS TO THE IV. 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 24027960 ↗
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
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.