Medline Industries, Inc. PAIN1903BRecalls & reported problems
Medline Industries, Inc. · CSE-TUOHY17GX3.5/WHITACRE25GX5 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10195327628529), received between Mar 10, 2026 and Sep 28, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Deliver2
- Failure to Infuse2
- Blocked Connection1
- Incomplete or Inadequate Connection1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Obstruction of Flow; Blocked Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917403 ↗MalfunctionSep 14, 2026Incomplete or Inadequate Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765523 ↗MalfunctionMar 16, 2026Failure to Deliver; Failure to Infuse
ACCORDING TO THE FACILITY ON (B)(6) 2026, AFTER PLACEMENT WE COULDN'T INJECT THE TEST DOSE VIA THE EPIDURAL CATHETER. 3X ATTEMPTS WITH HIGH PRESSURE WERE UNSUCCESSFUL WITH DIFFERENT SYRINGES. THE CHANGE OF THE CONNECTING DEVICE WASN'T SUCCESSFUL EITHER. THE CATHETER WAS THEREFORE REMOVED, AND A NEW MEDLINE CSE KIT WAS USED MAKING SURE THAT THE CATHETER IS PATENT BEFORE PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606489 ↗MalfunctionMar 11, 2026Failure to Deliver
ACCORDING TO THE FACILITY, AFTER PLACEMENT WE COULDN'T INJECT THE TEST DOSE VIA THE EPIDURAL CATHETER. 3X ATTEMPTS WITH HIGH PRESSURE WERE UNSUCCESSFUL WITH DIFFERENT SYRINGES. THE CHANGE OF THE CONNECTING DEVICE WASN'T SUCCESSFUL EITHER. THE CATHETER WAS THEREFORE REMOVED AND A NEW MEDLINE CSE KIT WAS USED MAKING SURE THAT THE CATHETER IS PATENT BEFORE PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24569542 ↗MalfunctionMar 10, 2026Failure to Infuse
ACCORDING TO THE FACILITY ON (B)(6) 2026, AFTER PLACEMENT WE COULDN'T INJECT THE TEST DOSE VIA THE EPIDURAL CATHETER. 3X ATTEMPTS WITH HIGH PRESSURE WERE UNSUCCESSFUL WITH DIFFERENT SYRINGES. THE CHANGE OF THE CONNECTING DEVICE WASN'T SUCCESSFUL EITHER.
Patient problems: Insufficient Information
MAUDE report 24561381 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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