NA ACT5612Recalls & reported problems
Baxter International Inc. · Extension Set, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00085412079714), received between May 29, 2019 and Nov 21, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.
Most reported problems
Device problems
- Fluid/Blood Leak4
- Disconnection3
- Material Puncture/Hole1
Patient problems
- No Consequences Or Impact To Patient3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT THE LUER LOCK OF THE EXTENSION SET "KEEPS POPPING OFF DURING USE". THIS ISSUE RESULTED IN "BLOOD LOSS OF FREW ML". 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 9354448 ↗MalfunctionNov 20, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT THE LUER LOCK OF THE EXTENSION SET KEEPS POPPING OFF DURING USE. THIS ISSUE RESULTED IN A LEAK OF AN UNSPECIFIED VOLUME OF BLOOD. 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 9349844 ↗MalfunctionNov 20, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT THE LUER LOCK OF THE EXTENSION SET KEEPS POPPING OFF DURING USE. THIS ISSUE RESULTED IN A LEAK OF AN UNSPECIFIED VOLUME OF BLOOD. 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 9348360 ↗MalfunctionMay 29, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THERE WERE HOLES IN THE TUBING OF FOUR (4) EXTENSION SETS WHICH CAUSED FLUID TO LEAK ONTO THE FLOOR. THE LEAKS WERE DISCOVERED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 8651932 ↗
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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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