Bardia® Closed System Foley Catheter Tray 802016Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741019678), received between Mar 19, 2018 and Aug 3, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Component Missing” (6 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE PATIENT RECEIVED FOLEY TRAYS WITHOUT KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156628 ↗
• MalfunctionDec 6, 2019Inaccurate Flow Rate; Restricted Flow rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY HAD A RESTRICTED FLOWRATE, WHICH CAUSED A NURSE TO HAVE TO REMOVE THE FOLEY AND PLACE A NEW ONE.

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

  MAUDE report 9423934 ↗
• MalfunctionMay 14, 2019Component Missing; Therapeutic or Diagnostic Output Failure; Component Missing

  IT WAS REPORTED THAT THE LUBRICANT WAS MISSING FROM THE TRAY.

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

  MAUDE report 8607592 ↗
• MalfunctionApr 9, 2019Component Missing; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE BAG WAS MISSING THE PART THAT SCREWS ONTO THE CATHETER MAKING THE DEVICE UNUSABLE. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8494996 ↗
• InjuryJan 23, 2019Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT FELT THAT HIS URINARY TRACT INFECTIONS WERE CAUSED BY THE IODINE BEING PROVIDED SEPARATELY INSTEAD OF IN THE KIT.

  Patient problems: Urinary Tract Infection

  MAUDE report 8270171 ↗
• MalfunctionOct 24, 2018Component Missing

  IT WAS REPORTED THAT THE LUBRICATING JELLY WAS MISSING FROM THE CATHETER TRAY.

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

  MAUDE report 8002068 ↗
• MalfunctionMar 23, 2018Component Missing

  IT WAS REPORTED THAT THE LUBRICANT PACKET AND BETADINE SWABS WERE MISSING FROM THE CATHETER TRAY. IT WAS REPORTED THAT THE NURSE OPENED A SECOND TRAY, TOOK THE SWABS AND LUBRICANT, TO BE ABLE TO USE THE CATHETER FROM THE TRAY WITH THE MISSING COMPONENTS.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7367378 ↗
• MalfunctionMar 19, 2018Component Missing

  IT WAS REPORTED THAT THE LUBRICANT PACKET AND BETADINE SWABS WERE MISSING FROM THE CATHETER TRAY. IT WAS REPORTED THAT THE NURSE OPENED A SECOND TRAY AND TOOK THE SWABS AND LUBRICANT TO BE ABLE TO USE THE CATHETER FROM THE TRAY WITH THE MISSING COMPONENTS.

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

  MAUDE report 7349141 ↗