EXTENSION SET 2N3382Recalls & reported problems
Baxter Healthcare Corporation · Micro-Volume Extension Set with 0.2 m Filter · Class 2
All models of EXTENSION SET (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00085412653297), received between Apr 19, 2021 and Sep 11, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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
- Fluid/Blood Leak14
- No Flow3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741193 ↗MalfunctionSep 9, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699090 ↗MalfunctionJun 5, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A UNSPECIFIED QUANTITY OF MICRO-VOLUME EXTENSION SETS WITH 0.2 M FILTER WERE LEAKING FROM THE AIR VENTING MECHANISM. THE PROCESS STEP AT WHICH THE ISSUE OCCURRED WAS NOT SPECIFIED. IT WAS STATED THAT USERS MANUALLY PRIME THE LINES, OCCASIONALLY USING SYRINGES SMALLER THAN 10ML. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25417142 ↗MalfunctionJun 3, 2026Fluid/Blood Leak
IT WAS REPORTED THAT FOUR (4) MICRO-VOLUME EXTENSION SETS WITH 0.2 MICRON FILTER LEAKED FROM THE AIR VENTING MECHANISM. THIS OCCURRED DURING 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 25385492 ↗MalfunctionMay 29, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET WITH 0.2 M FILTER LEAKED FROM THE AIR VENTING MECHANISM. THE PROCESS STEP AT WHICH THE ISSUE OCCURRED WAS NOT SPECIFIED. IT WAS STATED THAT USERS MANUALLY PRIME THE LINES, OCCASIONALLY USING SYRINGES SMALLER THAN 10ML. THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25338353 ↗MalfunctionAug 7, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MICRO-VOLUME EXTENSION SETS LEAKED FROM THE FILTER. THIS OCCURRED PRIOR TO PATIENT USE. THE SETS WERE NOT USED WITH A POWER INJECTOR. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929388 ↗MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MICRO-VOLUME EXTENSION SETS LEAKED FROM THE FILTER. 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 19812748 ↗MalfunctionAug 16, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED AT THE FEMALE ADAPTER. THIS WAS DISCOVERED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17557996 ↗MalfunctionAug 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED AT THE FILTER. 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 17542007 ↗MalfunctionAug 1, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY [AT LEAST TWO (2)] MICRO-VOLUME EXTENSION SETS LEAKED AT THE CONNECTION OF THE TUBING TO THE FEMALE ADAPTER. THIS WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17434214 ↗MalfunctionJun 16, 2023Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow
IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED. THE ISSUE OCCURRED DURING PATIENT INFUSION OF FUROSEMIDE AND CHLOROTHIAZIDE. 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 17146906 ↗MalfunctionJul 25, 2022No Flow; No Flow
IT WAS REPORTED AN UNSPECIFIED QUANTITY OF MICRO-VOLUME EXTENSION SETS WOULD NOT FLOW. FURTHERMORE, ¿MEDICATIONS (SUCH AS BUSULFAN 0.5 MG/ML) NOT FLOWING PAST THE FILTER¿. THE EVENT OCCURRED DURING AN UNKNOWN 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 15099232 ↗MalfunctionJul 25, 2022Break; Break
IT WAS REPORTED THE TUBING OF AN UNSPECIFIED QUANTITY OF MICRO-VOLUME EXTENSION SETS BROKE (NOT FURTHER SPECIFIED). THE EVENT OCCURRED DURING AN UNKNOWN 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 15094630 ↗MalfunctionJul 25, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AN UNSPECIFIED QUANTITY OF MICRO-VOLUME EXTENSION SETS LEAKED ¿AT THE CONNECTION POINTS¿. THE EVENT OCCURRED DURING AN UNKNOWN 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 15094627 ↗MalfunctionApr 21, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A MICRO-VOLUME EXTENSION SET LEAKED. AFTER THE LINE WAS PRIMED A LEAK WAS OBSERVED AT THE FILTER. THE SET WAS CHANGED. 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 11704359 ↗MalfunctionApr 21, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED AT THE FILTER. THE EVENT OCCURRED DURING PATIENT USE. 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 11701012 ↗MalfunctionApr 19, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED FIVE (5) MICRO-VOLUME EXTENSION SETS LEAKED. THE LEAK WAS OBSERVED AT THE FILTER. THE EVENT OCCURRED DURING AN UNKNOWN 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 11690635 ↗
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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 16, 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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