Bard® Suction Catheter Two Eye, Whistle Tip With Control Vent 0360100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741052453), received between Dec 5, 2018 and May 29, 2019 — classified as 3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2019Material Twisted/Bent

  IT WAS REPORTED THAT 14 CATHETERS WERE BENT IN THE PACKAGING.

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

  MAUDE report 8651480 ↗
• MalfunctionDec 5, 2018Incorrect Measurement; Incorrect Measurement; Failure of Device to Self-Test

  IT WAS REPORTED THAT THE PLASTIC SUCTION CATHETER 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 8134783 ↗
• MalfunctionDec 5, 2018Nonstandard Device; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT THE PLASTIC SUCTION CATHETER 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 8134780 ↗