CARDINAL HEALTH SENHDBUNODRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439181555), received between Dec 5, 2025 and Dec 5, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 18, 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.

• MalfunctionDec 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A CATEGORY 2 CAESAREAN SECTION IN MATERNITY THEATRE 2, A URINARY CATHETER WAS INSERTED BY THE MIDWIFE AS PART OF THE STANDARD PRE-OPERATIVE PROCEDURE. ONLY A SMALL AMOUNT OF URINE DRAINED AT THE TIME OF INSERTION, BUT THE CATHETER WAS CONFIRMED TO BE IN SITU. THE CATHETER USED WAS FROM THE NEW BARD CATHETER TRAY (SIZE 12CH, REF (B)(4), LOT NGKQ2734). UPON COMPLETION OF SURGERY, WHEN THE PATIENT LEGS WERE MOVED FOR CLEANING, THE HEALTH CARE ASSISTANT OBSERVED THAT NO URINE WAS PRESENT IN THE CATHETER TUBING. IT WAS THEN IDENTIFIED THAT THE CATHETER HAD BECOME DISLODGED, WITH THE BALLOON ALREADY DEFLATED AND THE CATHETER LIED BETWEEN THE PATIENT LEGS. THE OPERATING SURGEON WAS INFORMED AND REQUESTED THAT THE CATHETER BE REPLACED USING THE PREVIOUS SINGLE CATHETER SYSTEM RATHER THAN THE NEW BARD TRAY. THE REPLACEMENT WAS COMPLETED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728743 ↗