PremierPro™ 31T20116Recalls & reported problems
Prestige Ameritech, Ltd. · PremierPro™ by MedSource TrueSafe Comfort® Safety IV Catheter, 20G x 1.16in, 1 each · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811220034528), received between Jan 17, 2025 and Jan 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Misassembled” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Component Misassembled1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2025Component Misassembled; Component Misassembled
I WAS STARTING AN IV ON A PATIENT, AND WHEN I HIT THE NEEDLE RETRACT BUTTON, THE NEEDLE FLEW OUT THE BACK END AND HIT ME IN THE LEG. I DID NOT SEE ANY MARKS THAT MAKE ME THINK THE NEEDLE STUCK ME, I AM PRETTY CERTAIN I GOT HIT WITH THE BACK END OF THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21182150 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.