Bardia® Complete Foley Kit 800316Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741040290), received between Aug 22, 2019 and Aug 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2019Partial Blockage; Insufficient Flow or Under Infusion; Partial Blockage

  IT WAS REPORTED THAT WHEN ATTEMPTING TO INJECT WATER THROUGH THE STUCK VALVE, WATER PASSED THROUGH THE VALVE. HOWEVER, THERE SEEMED TO BE SOME TYPE OF BLOCKAGE OR LOCK AROUND THE SYRINGE TIP THAT DID NOT ALLOW A COMPLETE FLOW OF THE WATER . NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8922932 ↗