Lubri-Sil® I.C. Complete Care® Temperature-Sensing Urine Meter Foley Tray 319214ARecalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00801741040153), received between Dec 9, 2019 and Aug 26, 2026 — classified as 107 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (76 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 25 most recent of 107 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50454731 ↗
• MalfunctionFeb 25, 2026Inflation Problem; Fitting Problem

  IT WAS REPORTED THAT AFTER INSERTING THE FOLEY CATHETER TO THE PATIENT IN THE OPERATING ROOM, WATER COULD NOT BE INFUSED, AND LEAKAGE WAS CONFIRMED FROM THE VALVE, SO REMOVAL WAS DECIDED. THEN TRIED TO WITHDRAW WATER USING A SYRINGE, BUT IT COULD NOT BE DRAWN AT ALL. THE CATHETER WAS REMOVED, LEAVING A SMALL AMOUNT OF STERILE WATER REMAINING. NO BLEEDING OR OTHER ISSUES WERE OBSERVED. THE TROUBLESHOOTING PROCEDURE IN THE NOTICE DOCUMENT WAS TRIED AND STILL NOT ABLE TO WITHDRAW WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24448061 ↗
• MalfunctionOct 28, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A HEALTH PROFESSIONAL WAS UNABLE TO DRAIN ANY WATER IN THE FOLEY CATHETER DURING THE PRETEST. IT TOOK 12 HOURS TO DRAIN THE WATER. SINCE IT OCCURRED DURING PRETESTING, NO MEASURES WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408552 ↗
• MalfunctionOct 24, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS HAIR CONTAMINATION IN THE FOLEY TRAY NEAR THE URINE OUTLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384583 ↗
• MalfunctionOct 24, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN A FOLEY TRAY WAS OPENED IN THE OPERATING ROOM FOR CATHETERIZATION AND TEMPERATURE MANAGEMENT, A BLACK FOREIGN OBJECT WAS FOUND INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380216 ↗
• MalfunctionOct 22, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PRETEST, STERILIZED WATER COULD NOT BE DRAWN FROM THE FOLEY CATHETER. PER NOTIFICATION FROM INVESTIGATOR ON 20FEB2026, IT WAS REPORTED THAT AFTER DEFLATION CUFFING WAS PRESENT DURING SAMPLE EVALUATION ON 03FEB2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357717 ↗
• MalfunctionOct 21, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE DISINFECTANT LEAKED FROM INSIDE THE STERILIZATION PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350491 ↗
• MalfunctionOct 15, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PRETEST IN THE OPERATING ROOM, AFTER INJECTING THE FOLEY CATHETER STERILE WATER, WATER COULD NOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278728 ↗
• MalfunctionOct 10, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS NO COTTON BALL INSIDE THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23267247 ↗
• MalfunctionOct 10, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING TESTING THE FOLEY CATHETER STERILE WATER DID NOT RETURN. IT HAD DIFFICULTY TO DRAIN WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266000 ↗
• MalfunctionOct 2, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE USER TRIED TO DRAIN THE WATER DURING A CUFF CHECK OF THE FOLEY CATHETER BUT HAD TO PULL THE PLUNGER QUITE HARD TO DRAIN THE WATER. ALL OF THE WATER HAD BEEN EXTRACTED WHEN THE CAT WAS LEFT IN THE CARE OF THE OWNER, BUT WHEN WE TESTED IT OURSELVES, IT WAS STILL QUITE DIFFICULT TO EXTRACT. THE FACILITY TRIED USING OTHER SYRINGES AND IT WAS THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23199678 ↗
• MalfunctionSep 25, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT BEFORE USE THE FOLEY CATHETER INFLATION VALVE WAS STIFF AND CAME OFF ALONG WITH THE SYRINGE. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 23SEP2025, STATED THAT IT WAS UNCLEAR WHETHER THE EVENT OCCURRED WAS DURING WATER INJECTION OR WITHDRAWAL, BUT THE SYRINGE OPERATION FELT STIFF. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 24SEP2025, STATED THAT THE FOLEY CATHETER VALVE WAS DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23142547 ↗
• MalfunctionSep 17, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PRE-TEST, THE INJECTED STERILE WATER INSIDE THE FOLEY CATHETER DID NOT COME OUT. PER NOTIFICATION FROM INVESTIGATOR ON 02FEB2026, IT WAS REPORTED THAT THE BALLOON WAS NOTED TO INFLATED ASYMMETRICALLY, FOUND DURING SAMPLE EVALUATION ON 24DEC2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073668 ↗
• MalfunctionSep 16, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE FOLEY CATHETER CUFF TEST, THE STERILE DISTILLED WATER DID NOT DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066579 ↗
• MalfunctionSep 16, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT, AFTER OPENING THE FOLEY TRAY, NO SYRINGE WAS FOUND INSIDE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063376 ↗
• MalfunctionSep 11, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT, DURING PRETESTING STERILE WATER COULD NOT BE DRAWN FROM FOLEY CATHETER. PER THE NOTIFICATION RECEIVED FROM THE INVESTIGATOR ON 29JAN2026, IT WAS REPORTED THAT THE BALLOON OF CATHETER HAD BEEN ASYMMETRICAL AT 80/20, AND CUFFING NOTED DURING SAMPLE EVALUATION ON 23DEC2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025503 ↗
• MalfunctionAug 6, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PRE-TEST, IT BECAME DIFFICULT TO DRAIN THE WATER FROM FOLEY CATHETER, AND IT BECAME UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727583 ↗
• MalfunctionAug 1, 2025Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY CATHETER TAMPER EVIDENT SEAL WAS BROKEN FROM THE START.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686655 ↗
• MalfunctionJul 28, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT PRE-TEST SHOWED THAT THE FOLEY CATHETER BALLOON INFLATED ASYMMETRICALLY. PER INVESTIGATOR'S NOTIFICATION RECEIVED ON 25JUL2025, IT WAS REPORTED THAT DIFFICULT TO DEFLATE AGAINST THE SYRINGE WAS FOUND DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629452 ↗
• MalfunctionJul 25, 2025Material Puncture/Hole; Component Misassembled; Material Puncture/Hole; Component Misassembled

  IT WAS REPORTED THAT DURING FOLEY CATHETER PLACEMENT THE STERILE WATER LEAKED FROM THE FUNNEL, AND NOTHING CAME IN CONTACT WITH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609235 ↗
• MalfunctionJul 24, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE WHEN TRIED TO USE A FOLEY TRAY SYRINGE CONTAINING STERILE WATER, THE TIP HAD DISCOLORED AND THERE WERE FLOATING OBJECTS IN THE STERILE WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587345 ↗
• MalfunctionJul 3, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE PHYSICIAN FOUND INSECTS INSIDE THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396905 ↗
• MalfunctionJun 25, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT WHEN THEY OPENED PACKAGE IN THE OPERATING ROOM TO PLACE A FOLEY CATHETER FOR URINARY CATHETERIZATION AND TEMPERATURE CONTROL, THEY FOUND THAT THE CATHETER WAS NOT ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329820 ↗
• MalfunctionJun 25, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT WHEN A PRE-TEST WAS CONDUCTED IN THE OPERATING ROOM TO INSERT A FOLEY CATHETER FOR URINARY CATHETERIZATION AND TEMPERATURE CONTROL, STERILE WATER DID NOT COME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329780 ↗
• MalfunctionJun 25, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHEN A PRE-TEST WAS CONDUCTED IN THE OPERATING ROOM TO PLACE A FOLEY CATHETER FOR URINARY CATHETERIZATION AND TEMPERATURE CONTROL, IT WAS FOUND THAT STERILE WATER COULD NOT BE INJECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329118 ↗