NA 2C6226Recalls & reported problems
Baxter International Inc. · Extension Set, Male Luer Lock Adapter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00085412003900), received between May 20, 2024 and Aug 14, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (3 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
- Difficult to Open or Remove Packaging Material3
- Detachment of Device or Device Component1
- Disconnection1
- Failure to Infuse1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2026Difficult to Open or Remove Packaging Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262995 ↗MalfunctionAug 14, 2026Difficult to Open or Remove Packaging Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262885 ↗InjuryApr 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED AN EXTENSION SET SEPARATED DURING SURGERY. DURING THE INDUCTION OF ANESTHESIA, A PATIENT WAS RECEIVING PROPOFOL AND ROCURONIUM WHEN THE EXTENSION SET SEPARATED; FURTHER REPORTED AS "THE TUBING APPEARED TO FALL OUT OF THE MALE PORTION OF THE EXTENSION TUBING". THE SURGICAL TEAM WAS UNABLE TO ADMINISTER MEDICATIONS THROUGH THE EXTENSION SET DUE TO THIS MALFUNCTION; FURTHERMORE, DUE TO THE LOCATION OF THE SEPARATION, IT WAS NOT POSSIBLE TO CONNECT A NEW INTRAVENOUS LINE TO THE EXTENSION SET. IT WAS ALSO REPORTED THAT THE ADAPTER WAS TOO TIGHT TO DISENGAGE FROM THE ANGIOCATH THAT IT WAS ATTACHED TO. AS A RESULT, A NEW INTRAVENOUS LINE WAS QUICKLY ESTABLISHED WHILE THE PATIENT¿S AIRWAY WAS MAINTAINED VIA BAG AND MASK. THE SURGERY WAS COMPLETED WITHOUT FURTHER ISSUE. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21762132 ↗MalfunctionDec 17, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT THE STERILE PACKAGE OF AN EXTENSION SET WAS DIFFICULT TO OPEN. THIS ISSUE WAS DESCRIBED AS, ¿WHEN THEY TRYING TO OPEN, THE PACKAGE BEGINS RIPPING. APPARENTLY, THE SEAL IS TOO STRONG, SHREDDING THE PACKAGE.¿ THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20952452 ↗MalfunctionMay 20, 2024Disconnection; Fluid/Blood Leak; Failure to Infuse; Disconnection; Fluid/Blood Leak; Failure to Infuse
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXTENSION SETS LEAKED. THE EVENT OCCURS AFTER THE USER ATTACHED THE EXTENSION TUBING TO THE PATIENT¿S PERIPHERAL IV (CATHETER HUB). THE IV TUBING SEPARATES FROM THE CATHETER HUB AND SUBSEQUENTLY LEAKS AT THE SEPARATION OF THE CONNECTORS. THIS LEAK WOULD THEN PREVENT THE FULL VOLUME OF MEDICATION FROM BEING INFUSED. 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 19352208 ↗
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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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