ACS CDVA23GRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191072073327), received between Feb 11, 2020 and Feb 11, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

• MalfunctionFeb 11, 2020Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem

  WE JUST OPENED 2 STERILE PACKS THAT WERE BOTH CONTAMINATED DUE TO THE OUTER DRAPE OF THE PACK BEING DAMAGED. THEY WERE BOTH VASCULAR ACCESS PACKS LOT#664191 IT DOES NOT APPEAR THAT ALL OF THE PACKS WITH THIS LOT NUMBER ARE DAMAGED BUT WE DID OPEN 2 OF THEM THAT WERE, THE OUTER WRAPPER APPEARS FINE BUT THE ACTUAL DRAPE IS COMPROMISED THAT ACTUALLY ENDS UP COVERING THE TABLE. THEREFORE THE WHOLE SYSTEM HAS TO BE DISCARDED. POSSIBLE THAT THE POSITIONING OF THE PLASTIC SUPPLIES IN THE PACKS CONTRIBUTED TO THE HOLES. UNDERLYING THE HOLE ARE THE PLASTIC PITCHER AND BOWL.

  Patient problems: No Patient Involvement

  MAUDE report 9693361 ↗