SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A942616Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741100802), received between Feb 28, 2018 and Jul 18, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2019Device Damaged Prior to Use; Device Damaged Prior to Use; Malposition of Device; Scratched Material

  IT WAS REPORTED THAT THE HOOK THAT HANGS FROM THE DRAIN BAG WAS VERY SHARP AND CAUSED THE PATIENT'S SKIN TO TEAR. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Abrasion; Skin Tears

  MAUDE report 8802367 ↗
• InjuryJul 18, 2019Device Damaged Prior to Use; Device Damaged Prior to Use; Sharp Edges

  IT WAS REPORTED THAT THE HOOK THAT HANGS FROM THE DRAIN BAG WAS VERY SHARP AND CAUSED THE PATIENT TO BE CUT AND RECEIVED 4 STITCHES TO THEIR LEG.

  Patient problems: Abrasion; Laceration(s)

  MAUDE report 8802365 ↗
• MalfunctionFeb 15, 2019Break

  IT WAS REPORTED THAT UPON REMOVING THE CATHETER FROM THE TRAY, THE TIP WAS BROKEN OFF.

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

  MAUDE report 8343126 ↗
• MalfunctionSep 6, 2018Restricted Flow rate; Inaccurate Flow Rate; Restricted Flow rate

  IT WAS REPORTED THAT URINE WAS NOT DRAINING PROPERLY INTO THE DRAINAGE BAG. ALLEGEDLY, THE NURSES OFTEN HAVE TO MILK THE TUBING AND MOVE IT UP AND DOWN FOR THE URINE TO DRAIN. THE COMPLAINANT STATED THAT IT IS ALMOST LIKE THE TUBING IS STIFFER OR IT GETS AN AIR TRAP.

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

  MAUDE report 7850221 ↗
• MalfunctionFeb 28, 2018Gel Leak; Gel Leak; Leak/Splash

  IT WAS REPORTED THAT THE IODINE PACKET LEAKED IN THE TRAY. NO PATIENT INVOLVEMENT WAS REPORTED.

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

  MAUDE report 7303089 ↗