CARDINAL HEALTH SU130-0323 (UDI 10885380063992)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885380063992), received between Dec 9, 2016 and Dec 9, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 9, 2016Material Fragmentation

  (B)(4). PATIENT HAD SURGERY. SURGEON PLACED A ROUND 15 FRENCH SILICON DRAIN PRODUCED BY CARDINAL HEALTH IN THE AXILLA. PATIENT WAS SEEN IN THE OFFICE. WHEN DRAIN WAS REMOVED, IT TORE AND THE MAJORITY WAS LEFT IN THE PATIENT. PATIENT HAD RESIDUAL DRAIN REMOVED SIX DAYS LATER. THE PATIENT TOLERATED THE REMOVAL OF THE REMAINING PORTION OF THE DRAIN WELL WITH NO COMPLICATIONS. THERE WAS NO SUTURE OR OTHER OBVIOUS MECHANICAL REASON TO EXPLAIN WHY THE DRAIN TORE. PER QUALITY CHART REVIEW, THIS PATIENT DID NOT EXPERIENCE SERIOUS INJURY AS A RESULT OF THE INCOMPLETE REMOVAL OF THE DEVICE DURING THE INITIAL POST-OPERATIVE ATTEMPT TO REMOVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6159556 ↗