Plastic Cath'N Sleeve 0089100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741050206), received between Dec 5, 2018 and Dec 6, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (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.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 6, 2018Incorrect Measurement; Incorrect Measurement; Failure of Device to Self-Test

  IT WAS REPORTED THAT THE CATHETER FROM THE TRACHEAL SUCTION CATHETER KIT FAILED DIMENSIONAL ANALYSIS. THE PRODUCT WAS DETAINED AT THE BORDER BY FDA CUSTOMS, WHERE IT WAS RANDOMLY SELECTED TO BE SAMPLED AND SENT TO AN FDA SELECTED LABORATORY FOR INSPECTION.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8137233 ↗
• MalfunctionDec 5, 2018Nonstandard Device; Nonstandard Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CATHETER FROM THE TRACHEAL SUCTION CATHETER KIT FAILED VISUAL ANALYSIS. THE PRODUCT WAS DETAINED AT THE BORDER BY FDA CUSTOMS, WHERE IT WAS RANDOMLY SELECTED TO BE SAMPLED AND SENT TO AN FDA SELECTED LABORATORY FOR INSPECTION.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8134787 ↗