NA 2C5641Recalls & reported problems
Baxter International Inc. · Extension Set, Male Luer Lock Adapter with Retractable Collar · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00085412003818), received between May 2, 2019 and Dec 17, 2025 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (6 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material6
- Fluid/Blood Leak4
- Loose or Intermittent Connection4
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Patient Involvement4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN EXTENSION SET HAD PLASTIC FILM INSIDE THE FEMALE PORT. 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 23833946 ↗MalfunctionNov 26, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN EXTENSION SET HAD A POLYPROPYLENE PARTICLE. THIS WAS OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23661094 ↗MalfunctionAug 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTENSION SET WAS LEAKING FROM THE LUER LOCK. THIS ISSUE WAS OBSERVED WHILE CONNECTED TO A BAG OF BLOOD/HUMAN CELLS PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22772399 ↗MalfunctionJun 26, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) CONTAMINATION OBSERVED IN AN EXTENSION SET. THE PM WAS DESCRIBED AS, ¿POLYPROPYLENE PARTICLE WAS OBSERVED IN THE FINAL PRODUCT BAG BY USING THE GLOBAL EXTENSION SET¿. 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 22341206 ↗MalfunctionJun 7, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THREE (3) EXTENSION SETS LEAKED FROM THE FEMALE LUER CONNECTION WITH THE BLUE CAP. LIQUID WAS COMING AROUND THE SIDES OF THE CAP. THIS WAS IDENTIFIED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17080571 ↗MalfunctionMay 25, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXTENSION SETS HAD CONNECTION ISSUES; FURTHER DESCRIBED AS "WOULD NOT MAKE GOOD SEALS WHEN ATTEMPTING TO CONNECT VIA TUBE SEALERS". THE ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11876403 ↗MalfunctionMay 25, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXTENSION SETS HAD CONNECTION ISSUES; FURTHER DESCRIBED AS "WOULD NOT MAKE GOOD SEALS WHEN ATTEMPTING TO CONNECT VIA TUBE SEALERS". THE ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11876389 ↗MalfunctionMay 25, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXTENSION SETS HAD CONNECTION ISSUES; FURTHER DESCRIBED AS "WOULD NOT MAKE GOOD SEALS WHEN ATTEMPTING TO CONNECT VIA TUBE SEALERS". THE ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11876319 ↗MalfunctionMay 25, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXTENSION SETS HAD CONNECTION ISSUES; FURTHER DESCRIBED AS "WOULD NOT MAKE GOOD SEALS WHEN ATTEMPTING TO CONNECT VIA TUBE SEALERS". THE ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11876299 ↗MalfunctionSep 15, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A RED FIBER PARTICULATE WAS OBSERVED IN THE EXTENSION SET. IT WAS FURTHER REPORTED THAT THE PARTICULATE WAS FOUND TO BE AN ACRYLIC. THIS ISSUE WAS IDENTIFIED DURING CHECK. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 10535345 ↗MalfunctionSep 15, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A RED FIBER PARTICULATE WAS OBSERVED IN THE EXTENSION SET. IT WAS FURTHER REPORTED THAT THE PARTICULATE WAS FOUND TO BE AN ACRYLIC. THIS ISSUE WAS IDENTIFIED DURING CHECK. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 10535342 ↗MalfunctionJun 7, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTENSION SET WAS CRACKED WHICH RESULTED IN A LEAK. DURING FILLING, IT WAS DISCOVERED THAT THE FEMALE EXTENSION SET CONNECTED TO THE MALE STOPCOCK ASSEMBLY WAS CRACKED WHICH CAUSED A LEAK. 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 8680499 ↗MalfunctionMay 29, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PARTICULATE MATTER WAS OBSERVED DURING USE OF AN EXTENSION SET. THE PARTICULATE MATTER WAS NOTED IN A ¿CRYOBAG¿ (NON-BAXTER PRODUCT) ATTACHED TO THE SET. THIS WAS IDENTIFIED IN THE FINAL PRODUCT PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 8652285 ↗MalfunctionMay 2, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED ONE EXTENSION SET CRACKED, CAUSING A LEAK. THE CRACK WAS FURTHER DESCRIBED AS " THE FEMALE EXTENSION SET CONNECTED TO THE MALE STOPCOCK ASSEMBLY WAS DISCOVERED TO BE CRACKED". THIS WAS NOTED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 8575066 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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