MedSource ClearSafe Comfort IV Catheter (PUR) 22g x 1 MS-84222Recalls & reported problems
Medsource International LLC · ClearSafe Comfort IV Catheter (PUR) 22g x 1 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816703020647), received between Jul 10, 2025 and Jan 2, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2026Material Split, Cut or Torn
CATHETER DETACHED AND WENT INTO THE VEIN.
Patient problems: Foreign Body In Patient
MAUDE report 23949811 ↗InjuryJul 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
THE PLASTIC CATHETER DETACHED INSIDE THE VEIN.
Patient problems: Foreign Body In Patient
MAUDE report 22475097 ↗
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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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