SUB-Q-SET 1M8463Recalls & reported problems
Baxter Healthcare Corporation · Subcutaneous Infusion Set · 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 00085412013480), received between Jun 14, 2021 and Dec 29, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Obstruction of Flow3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2022Break; Break
IT WAS REPORTED THAT THE NEEDLE OF FOUR SUB-Q-SET SUBCUTANEOUS INFUSION SETS WITH A 27-GAUGE NEEDLE WERE NOT BEVELED IN WHICH THE SUBCUTANEOUS DISC MEDICATION COULD NOT BE PLACED. THIS WAS OBSERVED DURING SETUP AND PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16069537 ↗MalfunctionJun 15, 2021Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO PUSH FLUID THROUGH THE LINE OF AN UNSPECIFIED QUANTITY OF SUB-Q-SET SUBCUTANEOUS INFUSION SETS. THIS ISSUE OCCURRED WHILE ATTEMPTING TO FLUSH THE LINES PRIOR TO PATIENT THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12005645 ↗MalfunctionJun 15, 2021Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO PUSH FLUID THROUGH THE LINE OF AN UNSPECIFIED QUANTITY OF SUB-Q-SET SUBCUTANEOUS INFUSION SETS. THIS ISSUE OCCURRED WHILE ATTEMPTING TO FLUSH THE LINES PRIOR TO PATIENT THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12000004 ↗MalfunctionJun 14, 2021Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE LINES OF FIVE (5) SUBCUTANEOUS INFUSION SETS WERE PLUGGED. IT WAS FURTHER REPORTED THAT UNSPECIFIED FLUID COULD NOT BE FLUSHED THROUGH THE LINE. THIS 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 11992858 ↗
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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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