Bardia® Urethral Catheter 802412Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741018343), received between Jun 28, 2017 and Mar 18, 2021 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Misassembled” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO INFECTIONS AND BELIEVED IT IS FROM THE BARDIA URETHRAL CATHETER PRODUCT. THE PATIENT ALSO SAID WHEN THE ORDER WAS ARRIVED IT APPEARED TO HAVE BEEN RAINED ON AND IT SEEMED THE BOX WAS RETAPED.

  Patient problems: Unspecified Infection

  MAUDE report 11518567 ↗
• MalfunctionDec 30, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THERE WERE BUMPS ON THE CATHETER AND THOSE WERE VERY VISIBLE. IT WAS ALSO REPORTED THAT THE PATIENT HAD ONE TO RETURN IF NEEDED, BUT HAD BEEN REUSING THEM SINCE BEING LOW ON SUPPLIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11098339 ↗
• MalfunctionDec 23, 2020Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE 12 FRENCH STRAIGHT TIP CATHETERS WERE PIERCED LIKE A KNIFE AND HENCE, IT COULD NOT BE USED. THE PATIENT NEEDED A 14 FRENCH COUDE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11065394 ↗
• MalfunctionJun 26, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETERS WERE IN DIFFERENT SIZES WHICH WERE NOT CONSISTENT AND ALSO NOTED THAT IT HURTS THE PATIENT.

  Patient problems: Pain

  MAUDE report 10200511 ↗
• MalfunctionJan 3, 2020Misassembled; Misassembled; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE CATHETERS WERE ALL SQUARE , AND CAUSED DISCOMFORT. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Discomfort

  MAUDE report 9547201 ↗
• MalfunctionSep 9, 2019Misassembled; No Flow; Misassembled

  IT WAS REPORTED THAT THE CATHETER HAD NO EYELETS, WHICH RESTRICTED THE FLOW. THE PATIENT ALLEGED THAT HE DID NOT NOTICE THE DEVICE DID NOT HAVE EYELETS UNTIL HE INSERTED THE DEVICE AND NO URINE FLOWED, WHERE HE SAW A SMALL AMOUNT OF BLOOD.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 8976485 ↗
• MalfunctionJul 25, 2018Misassembled; Defective Device; No Flow; Misassembled

  IT WAS REPORTED THAT THERE WERE NO DRAINAGE HOLES IN THE CATHETER. THE PATIENT ATTEMPTED TO USE THE CATHETER BUT SOON REALIZED THAT THE CATHETER DID NOT DRAIN.

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

  MAUDE report 7720125 ↗
• MalfunctionJul 24, 2018Device Damaged Prior to Use; Patient-Device Incompatibility; Material Integrity Problem; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE TIP OF THE CATHETER HAD A SHARP EDGE. THE PATIENT EXPERIENCED SKIN IRRITATION. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Skin Irritation

  MAUDE report 7716314 ↗
• MalfunctionJun 28, 2017Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CATHETER WAS SMALLER THAN USUAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6675060 ↗