Bard® Center Entry Foley Tray with Bardex® All Silicone Foley Catheter 897418Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741020308), received between Jul 31, 2019 and Oct 15, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2019Restricted Flow rate; Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THERE WAS A "FLAP" (EXTRA PIECE OF PLASTIC) IN THE BULB OF THE INLET TUBE ON THE DRAIN BAG THAT HAD TO BE PUSHED IN IN-ORDER FOR THE URINE TO FLOW AND WAS CAUSING A RESTRICTED FLOWRATE. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9194261 ↗
• MalfunctionAug 29, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT ONE OF THE PREVIOUS ITEMS FROM THIS LOT EXPERIENCED AIR LEAKAGE. AS A RESULT, THE FACILITY WOULD NOT USE ANY PRODUCT FROM THIS LOT NUMBER. CUSTOMER'S INVENTORY (7 CASES) WITH THIS LOT NUMBER WAS RETURNED AND REPLACED THROUGH CUSTOMER SERVICE FOR THE PRODUCT WITH A DIFFERENT LOT NUMBER.

  Patient problems: No Patient Involvement

  MAUDE report 8944662 ↗
• MalfunctionJul 31, 2019Deflation Problem; Deflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED IN THE PATIENT DURING THE NIGHT AND WAS FOUND ON THE BED OUTSIDE OF THE PATIENT THE NEXT MORNING. ANOTHER KIT WAS OBTAINED AND THE CATHETER WAS INSERTED BY THE DAY STAFF. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8846602 ↗