Lubri-Sil® I.C. Complete Care® All-Silicone Foley Catheter Tray and Urine Meter 303416ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741024726), received between Dec 6, 2018 and Jul 14, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 25, 2026Class IIOpen, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3115-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Material Puncture/Hole; Device Dislodged or Dislocated; Material Puncture/Hole; Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOLEY CATHETER CAME OUT OF THE PATIENT DURING SURGERY. CATHETER'S BALLOON WOULD SLOWLY DEFLATE SHORTLY AFTER INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495438 ↗
• MalfunctionMay 8, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SYRINGE IN A FOLEY TRAY SHOULD BE FILLED WITH STERILE WATER, THIS ONE APPEARS TO HAVE A PIECE OF METAL IN IT. THEY WERE CHECKING OTHER KIT WITH THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19268105 ↗
• MalfunctionSep 1, 2022Gel Leak; Gel Leak

  IT WAS REPORTED THAT THERE WAS NO LUBRICANT IN THE LUBRICANT JELLY SYRINGE . IT WAS ALSO STATED THAT THE SYRINGE THAT WAS SUPPOSED TO CONTAIN SALINE DID NOT HAVE A PLUNGER AND THEREFORE THERE WAS NO SALINE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335082 ↗
• MalfunctionAug 30, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS NO LUBRICANT IN THE LUBRICANT JELLY SYRINGE. IT WAS ALSO STATED THAT THE SYRINGE THAT WAS SUPPOSED TO CONTAIN SALINE DID NOT HAVE A PLUNGER AND THEREFORE THERE WAS NO SALINE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321959 ↗
• MalfunctionOct 20, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE 10ML SYRINGE USED TO FILL THE FOLEY CATHETER BALLOON WAS BROKEN OFF IN THE PORT WHILE PLACING THE FOLEY CATHETER AND CUSTOMER DRAINED STERILE WATER OUT OF THE BALLOON. THE FOLEY CATHETER WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665681 ↗
• MalfunctionNov 9, 2020Therapeutic or Diagnostic Output Failure

  FAULTY INDWELLING URINARY CATHETER COLLECTION BAG DEVICE NOT DRAINING APPROPRIATELY. PATIENT, WITH ACTIVE INDWELLING URINARY CATHETER, COMPLAINED SHE HAD "URGE" TO URINATE AND WAS LAYING IN WET LINENS. URINE COLLECTION BAG APPEARED TO BE "SUCKING-IN" ON ITSELF. WALLS OF COLLECTION BAG WERE PULLED AWAY FROM EACH OTHER AND 900 ML OF URINE IMMEDIATELY DRAINED INTO BAG. RN WHO REPORTED NOTED THIS ISSUE HAS HAPPENED TWICE IN (B)(6) 2020. BARD FOLEY CATHETER LOT # NGER4082. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 10816153 ↗
• MalfunctionJul 2, 2020Burst Container or Vessel; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON RUPTURED DURING IRRIGATION. STAFF EXAMINATION OF FOLEY BALLOON AFTER REMOVAL OF THE CATHETER INDICATED RUPTURED EDGES AND APPEARED APPROXIMATED WITH PIECES INTACT.

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

  MAUDE report 10226779 ↗
• MalfunctionSep 25, 2019Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE USED TO INJECT FLUID INTO THE VALVE WAS FOUND UNCAPPED AND LEAKING IN THE TRAY. THE KIT WAS DISCARDED EXCEPT FOR THE SYRINGE. THE CAP WAS REPLACED AND SENT TO RISK MANAGEMENT.

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

  MAUDE report 9117650 ↗
• MalfunctionAug 30, 2019Fluid/Blood Leak; Contamination /Decontamination Problem

  NURSE GOT A FOLEY CATHETER INSERTION KIT FOR A PATIENT. WHEN SHE OPENED THE KIT AND CHECKED THE ITEMS INSIDE, SHE NOTICED THAT THE SYRINGE USED TO INJECT WATER INTO THE VALVE WAS UNCAPPED AND FLUID WAS NOTED IN THE AREA SURROUNDING THE SYRINGE. NOTE: THE KIT WAS DISCARDED EXCEPT FOR THE SYRINGE MENTIONED ABOVE. THE CAP WAS PLACED BEFORE SUBMITTING TO RISK MANAGER TO AVOID SPILLING OF THE REMAINING FLUID.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8949861 ↗
• MalfunctionDec 6, 2018Use of Device Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE LUBRICANT CAP OF THE SYRINGE WAS EXPELLED DURING URINATION. THE CATHETER HAD BEEN PLACED DURING A VAGINAL DELIVERY, AFTER THE PATIENT HAD RECEIVED AN EPIDURAL. THE PATIENT HAD DISCOMFORT UPON URINATION. A SMALL PLASTIC OBJECT, 6 X 12 MM IN SIZE, WAS EXPELLED. THE COMPLAINANT STATED THAT IT WOULD BE HELPFUL IF THE CAP OF THE LUBRICANT WAS NOT CLEAR, BUT INSTEAD A COLOR. ADDITIONAL INFORMATION WAS RECEIVED, VIA EMAIL, FROM THE COMPLAINANT ON (B)(6) 2018. THE CAP FELL OUT OF THE PATIENT APPROXIMATELY 2 WEEKS PRIOR TO HER POST PARTUM CHECK ON (B)(6) 2018. THE PATIENT URINATED THE CAP OUT. THE LUBRICANT WAS PLACED IN THE TRAY, AND THE CATHETER PLACED INTO THE LUBRICANT BEFORE INSERTION.

  Patient problems: Discomfort; Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8137208 ↗