NA 2N1194Recalls & reported problems
Baxter International Inc. · Non-DEHP Catheter Extension Set, Male Luer Lock Adapter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00085412064550), received between Mar 24, 2020 and Sep 9, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “No Flow” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- No Flow2
- Failure to Disconnect1
- Fluid/Blood Leak1
- Material Puncture/Hole1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT THE TUBING OF A NON-DEHP I.V. CATHETER EXTENSION SET WAS SERRATED INSIDE AN UNIMPACTED PACKAGING. THIS WAS DISCOVERED AFTER BEING CONNECTED TO A PATIENT, WHEN FLUSHING THE NEWLY PLACED INTRAVENOUS (IV) FOR PATENCY. 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 23010912 ↗MalfunctionAug 27, 2025No Flow; No Flow
IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT (AT LEAST 4) OF I.V. CATHETER EXTENSION SETS HAD NO FLOW ISSUES. THIS WAS OBSERVED AFTER PRIMING WITH NORMAL SALINE PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22906785 ↗MalfunctionJul 14, 2025No Flow; No Flow
IT WAS REPORTED THAT TWO (2) NON-DEHP I.V. CATHETER EXTENSION SETS COULD NOT BE FLUSHED WHILE TRYING TO DRAW LABS 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 22501286 ↗MalfunctionNov 8, 2021Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED THAT THE ROUND BLUE CAP OF A TEN (10) NON-DEHP I.V. CATHETER EXTENSION SETS WOULD NOT COME OFF. THE ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12775773 ↗MalfunctionMar 24, 2020Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT A MICRO HOLE WAS OBSERVED IN THE TUBING OF NON-DEHP I.V. CATHETER EXTENSION SET. THIS WAS IDENTIFIED 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 Consequences Or Impact To Patient
MAUDE report 9872354 ↗
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- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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