DeRoyal 89-7420Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756739702), received between Jul 17, 2019 and Jul 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 16, 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.

• MalfunctionJul 17, 2019Crack; Material Integrity Problem; Crack; Material Integrity Problem

  A CARDIAC CATH PACK CONTAINED A BD SYRINGE THAT HAD A SMALL HOLE. BLOOD WAS DRAWN INTO THE SYRINGE WITHOUT ISSUE, BUT WHEN PUSHING THE BLOOD BACK, THE BLOOD CAME OUT A SMALL HOLE IN THE SIDE OF THE SYRINGE. THE PHYSICIAN WAS EXPOSED TO BLOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800068 ↗