Bard® Clean-Cath® Intermittent Catheter 423716Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741038884), received between Nov 15, 2017 and May 24, 2021 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE COUDE INTERMITTENT CATHETER WAS HARD TO INSERT SINCE IT WAS NOT CURVED ENOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870612 ↗
• MalfunctionMay 14, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE COUDE INTERMITTENT CATHETERS WERE NOT ANGLED THE SAME WAY HENCE IT DID NOT GO IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11827113 ↗
• MalfunctionNov 2, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SOME COUDE INTERMITTENT CATHETERS WERE BENT AND TWISTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10773589 ↗
• MalfunctionJul 17, 2020Device Damaged Prior to Receipt by User; Material Twisted/Bent; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT SOME CATHETERS AND PACKAGES WERE BENT AND TWISTED.

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

  MAUDE report 10289033 ↗
• MalfunctionApr 28, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT 20 CATHETERS WERE BENT AND TWISTED AND WERE NOT ABLE TO BE USED FOR INSERTION BY THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10006313 ↗
• MalfunctionApr 10, 2020Material Twisted/Bent; Packaging Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETERS WERE BENT IN THE PACKAGING CAUSING THE PATIENT TO HAVE TO STRAIGHTEN THEM OUT BEFORE USE, WHICH CAUSED A DIFFICULT INSERTION. THE CUSTOMER WAS ABLE TO INSERT AND USE THE CATHETER TO VOID.

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

  MAUDE report 9950243 ↗
• MalfunctionMar 5, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ABOUT 70 PERCENT OF THE CATHETERS WERE NOT STRAIGHT. IT WAS STATED THAT THE PACKAGING OF THE CATHETERS WERE BENT. THEY HAD TO BE STRAIGHTENED BEFORE USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9795156 ↗
• MalfunctionJul 18, 2019Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE COUDE INTERMITTENT CATHETER BECAME CLOGGED WITH SURGICAL SILICONE THAT THE PATIENT WAS USING AS A LUBRICANT. THE PATIENT WAS UNABLE TO VOID.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8802296 ↗
• MalfunctionApr 11, 2019Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE SURFACE OF THE COUDE INTERMITTENT CATHETER WAS SHARP. THE PATIENT REPORTED THAT HE WAS CUT BY THE CATHETER AND BLED. NO PATIENT INJURY/MEDICAL INTERVENTION REPORTED.

  Patient problems: Abrasion; Hemorrhage/Blood Loss/Bleeding; Injury; Patient Problem/Medical Problem

  MAUDE report 8504895 ↗
• InjuryNov 15, 2017Difficult to Insert; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE CATHETER WAS TOO STIFF AND THE PATIENT EXPERIENCED DIFFICULTY INSERTING THE CATHETER. IT WAS NOTED THAT THE HE PATIENT HAD BEEN FEELING SICK FOR A FEW DAYS AND WENT TO THE EMERGENCY ROOM AFTER EXPERIENCING BLOOD IN HIS URINE AND A FEVER FOLLOWING THIS EVENT WITH THE CATHETER. THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION AND REMAINED IN THE HOSPITAL FOR A PERIOD OF THREE DAYS WHERE HE WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Complaint, Ill-Defined; Fever; Hematuria; Unspecified Infection

  MAUDE report 7033560 ↗