MedSource ClearSafe Comfort IV Catheter(PUR) 20g x 1 MS-842202Recalls & reported problems
Medsource International LLC · ClearSafe Comfort IV Catheter(PUR) 20g 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 00816703020630), received between Jun 4, 2024 and Jun 24, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Separation” (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 Separation2
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.
InjuryJun 24, 2024Material Separation; Material Separation
THE CUSTOMER ADVISED THAT A 37 YEAR OLD MALE PATIENT, WAS AT THE CLINIC TO RECEIVE VITAMIN THERAPY VIA IV. IT WAS ADVISED THAT AS THE CLINICAL STAFF WAS INSERTING THE CATHETER, IT BROKE OFF IN THE PATIENTS ARM. THE PATIENT WAS SENT TO THE EMERGENCY ROOM WHEN THE BREAKAGE OCCURRED ON (B)(6). THE OFFICE WAS ADVISED BY THE PATIENT THAT THE EMERGENCY ROOM WAS UNABLE TO REMOVED THE CATHETER AND WAS ADVISED TO WAIT A FEW DAYS FOR THE WOUND TO SETTLE BEFORE FOLLOWING UP WITH A PRIVATE SURGEON. THE PATIENT FOLLOWED UP WITH A PRIVATE SURGEON ON (B)(6) AND WAS AT THE SURGEONS' CLINIC FROM 9AM UNTIL 12PM, IN THE BED WITH THE SURGEON ATTEMPTING TO REMOVE THE BROKEN CATHETER. ULTIMATELY THE SURGEON ADVISED THAT THE CATHETER HAD SETTLED IN THE PATIENTS MUSCLE AND THEY ARE UNABLE TO SAFELY REMOVE IT AND IT WAS RECOMMENDED TO LEAVE IT ALONE.
Patient problems: Foreign Body In Patient
MAUDE report 19600252 ↗InjuryJun 4, 2024Material Separation; Material Separation
THERE WAS A REPORTED INCIDENT WHERE THE CATHETER BECAME DISCONNECTED FROM THE HUB. THE PATIENT WAS SENT TO THE ER TO HAVE THE BROKEN CATHETER SURGICALLY REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 19460715 ↗
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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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