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SuperFlex 31802Recalls & reported problems

Katena Products, Inc. · SuperFlex Punctum Plug 1.3mm D x 2.0mm L - 2 per box · Class U

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841668114537), received between Jul 19, 2023 and Sep 26, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Inaccurate Flow Rate2

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 26, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

    IT WAS REPORTED THAT THEY WERE AT (B)(6) MEDICAL CENTER IN THE PEDIATRIC INTENSIVE CARE UNIT. THERE WAS A PATIENT ON THE ARCTIC SUN DEVICE AND IT WAS GIVING A LOW FLOW. THEY ASSISTED WITH PROPERLY CONNECTING THE PAD AND ENSURED IT CLICKED. THE FLOW RATE WAS JUMPING FROM 0.2 UP TO 1.6 L/MIN AND THEN IT SEEMED TO HAD STABILIZED AT 0.8 L/MIN. THEY WANTED TO MAKE SURE EVERYTHING LOOKED GOOD BECAUSE THE NURSE HAD A HARD TIME GETTING THE PATIENT UP TO TARGET. IT WAS CONFIRMED WHEN THE PAD WAS FIRST CONNECTED AND PRIMING, THE FLOW RATE WOULD HAVE FLUCTUATED DRASTICALLY UNTIL FULLY PRIMED AND COULD HAVE TAKEN A COUPLE MINUTES. IT WAS ALSO CONFIRMED THEY HAD THE NEONATAL PAD ON THE PATIENT. THE TARGETED TEMPERATURE WAS 37C, PATIENT TEMPERATURE WAS 34.7C, AND WATER TEMPERATURE WAS 33.8C AND SEEMED TO BE RAISED. THEY STATED PATIENT WAS JUST RETURNED FROM IMAGING AND THE PATIENT TEMPERATURE WAS 34.5C PRIOR. THE TREND INDICATOR SHOWED THREE ARROWS DOWN BEFORE AND THEN SHOWED THERMONEUTRAL. REWARM RATE WAS 0.5C/HOUR. IT WAS EXPLAINED FOR NEONATAL PADS, THEY TYPICALLY SAW A WATER FLOW RATE OF 0.8 L/MIN OR ABOVE WAS ADEQUATE FOR THERAPY. IT WAS SUGGESTED TO THE NURSE TO KEEP A CLOSE EYE ON THE FLO

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17818256 ↗
  • MalfunctionJul 19, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

    IT WAS REPORTED THAT THE NEONATAL GEL PAD FLOW WAS SLOW AND HAD NEGATIVE PRESSURE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 17349933 ↗

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.