CARDINAL HEALTH PC3BOH036Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439821451), received between Oct 1, 2020 and Oct 1, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionOct 1, 2020Break

  CUSTOMER REPORTED THE TIBURON DRAPE A47042TNSA FROM THE ADULT OPEN HEART KIT PC3BOH036 FELL APART DURING A PROCEDURE AND A CONTAMINATION TO THE PATIENT OCCURRED. CUSTOMER WOULD NOT PROVIDE ANY OTHER DETAILS, EVENT DATE OR PATIENT DEMOGRAPHICS WHEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 10612904 ↗