Bardia® Foley Catheter Insertion Tray 802110Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741018268), received between Jun 29, 2017 and Apr 25, 2023 — classified as 5 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Component Missing” (16 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE BARDIA FOLEY CATHETER INSERTION TRAY WAS EMPTY, ONLY HAD THE PACKAGING MATERIAL AND NO MEDICAL PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808985 ↗
• MalfunctionOct 27, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE PATIENT WAS MISSING STERILE GEL. AS PER ADDITIONAL INFORMATION ON (B)(6) 2022, PATIENT STATED THE TOPS KEPT POPPING OFF THE LEG BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679467 ↗
• MalfunctionAug 10, 2022Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER INSERTION TRAY MISSING THE PIECE THAT GOES ON STOMACH. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199671 ↗
• InjuryJul 12, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE PATIENT WHEN OPENING THE KIT UP THERE WAS NO SWABS AND USED THE KIT ANYWAY. PATIENT FELT THAT'S MAYBE WHY PATIENT GOT AN INFECTION. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14987898 ↗
• InjuryMay 23, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE FOLEY CATHETER TRAY KIT USED FOR PATIENT WITH MULTIPLE SCLEROSIS. STATED THAT THE NURSE ATTENDANT NOTICED THE DISINFECTANT ON THE TIPS OF THE PROVIDED COTTON SWABS WERE CLEAR INSTEAD OF ORANGE. NURSE ATTENDANT USED IT ANYWAY, AND A FEW DAYS LATER, THE PATIENT EXPERIENCED SWELLING AND PAIN. NO MEDICAL INTERVENTION WAS REPORTED. AS PER THE FOLLOW-UP VIA EMAIL ON 24MAY2022, IT WAS REPORTED THAT THE FIRST OF THE THREE DEVICES WAS USED BY A REGISTERED NURSE APPROXIMATELY FOUR WEEKS AGO AND NOTICED THAT THE COTTON TIPS OF THE SWAB STICKS WERE NOT OF THE SAME COLOR AS PREVIOUS DEVICES. THE TIPS OF THE RECENT ONES USED WERE COATED WITH A CLEAR LIQUID, WHEREAS ONES USED IN THE PAST WERE OF A YELLOWISH-RED IODINE COLOR. THE NURSE DID PROCEED TO USE THEM IN THE SAME MANNER AS THEY HAD USED THE SWABS IN THE PAST, EVEN THOUGH THE TIPS WERE OF A DIFFERENT COLOR. APPROXIMATELY 36 HOURS LATER THE PATIENT NOTICED SWELLING ON THE LEFT SIDE OF THE OUTER VAGINA AND PATIENT WAS EXAMINED BY DOCTOR OF MEDICINE, WHO THEN PRESCRIBED FLUCONAZOLE ORAL TABLETS. THE NEXT DAY THE PATIENT BROKE OUT IN HIVES ALL OVER HER BODY AND HIVES WERE PAINFUL AND CAUSED SEVERE ITCHING. THE DOCTOR OF

  Patient problems: Itching Sensation; Pain; Skin Discoloration; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 14469399 ↗
• InjuryOct 4, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT FOLEY CATHETER LUBRICANT WAS HARD TO INSERT AND REMOVE FROM THE PATIENT. THE CUSTOMER THOUGHT PRODUCT MIGHT BE OLD. ALSO STATED THAT COUPLE OF URINARY TRACT INFECTION CAUSED BECAUSE OF RESISTANCE OF PUTTING ON AND REMOVING THE CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 12568270 ↗
• MalfunctionFeb 12, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY INSERTION TRAY DID NOT COME WITH THE SYRINGE OR SOLUTION. PATIENT STATED NURSE HAD TO USE TWO TRAYS FOR EACH INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11321362 ↗
• MalfunctionFeb 12, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY INSERTION TRAY DID NOT COME WITH THE SYRINGE OR SOLUTION. THE PATIENT STATED THAT THE NURSE HAD TO USE TWO TRAYS FOR EACH INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11321359 ↗
• MalfunctionAug 14, 2020Component Missing

  IT WAS REPORTED THAT THE IODINE SWAB STICK WAS MISSING FROM THE KIT.

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

  MAUDE report 10408199 ↗
• MalfunctionJul 10, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT THE STERILE WATER SYRINGE WAS MISSING FROM THE INSERTION TRAY.

  Patient problems: No Patient Involvement

  MAUDE report 8776688 ↗
• MalfunctionJul 10, 2019Component Missing

  IT WAS REPORTED THERE WERE MISSING SYRINGES.

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

  MAUDE report 8775989 ↗
• MalfunctionApr 4, 2019Component Missing

  IT WAS REPORTED THAT THE SYRINGES WERE MISSING FROM THE CATHETER TRAY.

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

  MAUDE report 8483548 ↗
• MalfunctionFeb 28, 2019Component Missing

  IT WAS REPORTED THAT THE TRAY KITS WERE MISSING THE LUBRICANT PACKETS. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8376945 ↗
• InjuryAug 23, 2018Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Use of Device Problem

  IT WAS REPORTED THAT AS A RESULT OF REINSERTING THE CATHETER, THE PATIENT EXPERIENCED A URINARY TRACT INFECTION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 7809740 ↗
• MalfunctionFeb 12, 2018Short Fill; Component Missing; Short Fill

  IT WAS REPORTED THAT UPON OPENING THE TRAY THE WATER SYRINGE WAS MISSING THE WATER TO INFLATE THE CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 7263272 ↗
• InjuryAug 11, 2017Component Missing

  IT WAS REPORTED THAT THE TRAY WAS MISSING THE LUBRICATION FOR THE CATHETER. THE PATIENT EXPERIENCED CONTINUOUS BLEEDING AFTER THE CATHETER WAS INSERTED WITHOUT LUBRICATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL, WHERE HE WAS TREATED FOR THE BLEEDING BY HIS PHYSICIAN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6789877 ↗
• MalfunctionJul 10, 2017Component Missing

  IT WAS REPORTED THAT THE TRAY WAS MISSING THE WATER-FILLED SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6699511 ↗
• MalfunctionJun 29, 2017Component Missing

  IT WAS REPORTED THAT THE INSERTION TRAY DID NOT CONTAIN A SYRINGE.

  Patient problems: No Information

  MAUDE report 6679880 ↗
• MalfunctionJun 29, 2017Component Missing

  IT WAS REPORTED THAT THE INSERTION TRAY DID NOT CONTAIN A SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6679854 ↗