Bardex® I.C. Complete Care® Foley Catheter Tray With Urine Meter 903316ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741024504), received between Aug 8, 2017 and Jul 30, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2019Fluid/Blood Leak; Detachment of Device or Device Component

  FOLEY CATHETER INSERTED IN URETHRA AND INTO THE BLADDER. URINE VISUALIZED IN DRAINAGE TUBE. STAFF INFLATED BALLOON FOR THE FIRST TIME THROUGH BALLOON PORT WITH 10ML OF PREPACKAGED STERILE WATER. UNSCREWED SYRINGE FROM BALLOON PORT, AND BALLOON PORT FELL OFF OF THE CATHETER. WATER LEAKED OUT FROM TUBING WHERE BALLOON PORT HAD BEEN. GENTLY PULLED CATHETER AND IT SLIPPED RIGHT OUT OF URETHRA. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8847829 ↗
• MalfunctionApr 23, 2019Inadequate Instructions for Healthcare Professional; Manufacturing, Packaging or Shipping Problem; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED PRODUCT 903316A IN A CASE LABELED 903318A LOT NGCU3646.

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

  MAUDE report 8539907 ↗
• MalfunctionAug 8, 2017No Flow

  IT WAS REPORTED THAT THE PATIENT HAD DRAINAGE IMPAIRMENT SHORTLY AFTER FOLEY PLACEMENT WITH A FULL TO RELATIVELY FULL BLADDER. ACCORDING TO THE CUSTOMER, THE DIRECTIONS FOR USE WERE FOLLOWED; HOWEVER, SUBSEQUENT FOLEYS HAD TO BE PLACED BEFORE DRAINAGE OCCURRED.

  Patient problems: Urinary Retention

  MAUDE report 6775501 ↗