IV3000 FRAME 6CMX7CM CE CTN OF 100 59410082Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00040565120584), received between Oct 14, 2020 and Aug 30, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT, BEFORE USE, IT WAS CONFIRMED THERE WAS A RESIN LUMP-LIKE FOREIGN SUBSTANCE UNDER THE FIXING TAPE OF THE IV3000 WINDOW FRAME 6X7CM CTN 100. AS THIS WAS NOTICE DURING SET UP OR INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389162 ↗
• MalfunctionJan 22, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PRODUCT WAS NOT ADHESIVE ENOUGH TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11219527 ↗
• MalfunctionDec 3, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE WINDOW FRAME PART OF THE PRODUCT. WHEN THE FRAME WAS REMOVED IN THE LAST ACTION TO APPLY THE DRESSING, THE FILM PEELED OFF FROM THE SKIN. NO PATIENT HARM. A BACKUP WAS AVAILABLE. NO INFORMATION ABOUT DELAY. THE SAMPLE WILL NOT BE RETURNED BECAUSE OF CONTAMINATION, AND NO PHOTO IS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10941819 ↗
• MalfunctionOct 14, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DRESSING WAS NOT ADHESIVE AND IT COULD NOT ADHERE TO THE SKIN TIGHTLY AFTER EMBEDDING THE INDWELLING NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10680847 ↗