Bardia® Foley Catheter Insertion Tray 802030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741018299), received between May 14, 2018 and Oct 17, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Component Missing” (5 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY CATHETER INSERTION TRAY WAS RECEIVED WITHOUT THE COMPONENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617041 ↗
• MalfunctionOct 14, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE INSERTION TRAY HAD MISSING COMPONENTS. THERE WAS NO PREFILLED SYRINGE OR ANYTHING TO REMOVE THE OLD LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606990 ↗
• MalfunctionDec 29, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT AT LEAST ONE OF THE FOLEY CATHETER TRAY RECEIVED WAS MISSING LUBRICANT. IT WAS ALSO REPORTED THAT THE FOLEY CATHETER WAS DEFECTIVE AS THE CATHETERS PATIENT HAD DID NOT DRAIN FOR A WEEK AND LEAKED. NURSE CHANGED THE FOLEY AND FOUND THE TIP LOOKED WEIRD AND THE HOLE WAS SMALL. IT WAS ALSO REPORTED THAT THE PATIENT'S CURRENT FOLEY CATHETER WAS ALSO LEAKING. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCTS FOR LESS THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13110971 ↗
• InjuryNov 20, 2018Patient-Device Incompatibility; Component Missing; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A URINARY TRACT INFECTION ALLEGEDLY BECAUSE OF THE MISSING THE IODINE. THE INSERTION TRAYS ARE CURRENTLY BEING MANUFACTURED WITHOUT THE IODINE DUE TO A MARKET WIDE SHORTAGE.

  Patient problems: Urinary Tract Infection

  MAUDE report 8091545 ↗
• MalfunctionOct 25, 2018Misassembled; Fluid/Blood Leak; Misassembled; Component Missing

  IT WAS REPORTED THAT THE WATER SYRINGE FOUND INSIDE OF THE FOLEY INSERTION TRAY WAS MISSING THE CAP CAUSING THE WATER TO LEAK.

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

  MAUDE report 8005455 ↗
• InjuryMay 14, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE CMA EXPERIENCED ITCHING AND SHAKY HANDS, AS WELL AS SHORTNESS OF BREATH AFTER USING THE GLOVES IN THE FOLEY TRAY. IT WAS REPORTED THAT THE CMA WAS GIVEN OVER-THE-COUNTER BENADRYL AND SENT TO THE ER. THE CMA RECEIVED AN UPDRAFT NEBULIZER TREATMENT, INTRAMUSCULAR INJECTIONS OF PREDNISONE AND BENADRYL, AND PEPCID BY MOUTH IN THE EMERGENCY DEPARTMENT TO TREAT THE SYSTEMIC RESPONSE.

  Patient problems: Itching Sensation; Respiratory Distress; Shaking/Tremors

  MAUDE report 7512227 ↗