Closed Wound Suction 0043670Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741049408), received between Oct 17, 2017 and Jun 11, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE CLOSED WOUND SUCTION KIT WAS FALLING APART AT THE POINT WHERE STICK THE TUBING INTO THE ACCORDION DRAIN. THE DRAINS WERE PUT TOGETHER IN THE OPERATING ROOM AND FOUND THAT THE DRAINS WERE EASY TO DISCONNECT WHEN THE TUBING WAS NOT INSERTED FULLY. PER FOLLOW UP ON (B)(6) 2021 THE CUSTOMER STATED IT WAS UNKNOWN WHETHER THE USER WAS INSERTING THE TROCAR TOO FAR INTO THE TUBING RESULTING IN DIFFICULTY IN REMOVAL OR SEPARATION. THE ISSUE OCCURRED WHEN THE NURSING STAFF CAME TO FIND THE TUBING DETACHED FROM THE DRAIN ON A POST OPERATIVE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982792 ↗
• MalfunctionOct 17, 2017Disconnection

  IT WAS REPORTED THAT THE EVACUATOR WAS DISCONNECTING FROM THE TUBING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6955632 ↗