IV3000-1-HAND 7X9CM PORTED-CARTON 4006Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05000223417369), received between Oct 2, 2020 and Mar 5, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CATHETER FIXATION, THE INSERTION OF A PERIPHERAL VENOUS CANNULA (PVK) RESULTED IN A GRADE 2-3 DECUBITUS ULCER ON THE FOREARM OF THE PATIENT USING AN IV3000 PORTED DRESSING. THE PLASTIC BODY OF THE PVK LIED DIRECTLY ON THE PATIENT'S SKIN. THIS MEANS THAT MOISTURE AND PRESSURE WERE DIRECTLY APPLIED TO THE SKIN AREA. IT WAS USUAL TO PLACE A FLEECE PAD UNDERNEATH, WHICH PREVENTED A DEFECT IN THE SKIN. HOWEVER, THIS FLEECE PAD WAS NO LONGER INCLUDED IN THE PVK PLASTER SETS WITH TRANSPARENT PLASTER MATERIAL AND WAS NOT AVAILABLE SEPARATELY. THIS MEANT A RISK FOR THE PATIENT. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS ADDRESSED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Ulcer

  MAUDE report 21532104 ↗
• MalfunctionJul 2, 2024Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT DURING WOUND TREATMENT, WHEN PRODUCTS WERE TAKEN OUT OF THE CARTON, IT WAS CONFIRMED TWO EDGES, OPENING AND SIDE, OF 14 POUCHES OF A IV3000 7X9CM CTN 100 HAVE NOT SEALED AND NO DRESSINGS IN THEM. TREATMENT WAS PERFORMED WITH BACK-UP DRESSINGS. AS THIS HAPPENED BEFORE TREATMENT, PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661411 ↗
• MalfunctionDec 29, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SET UP FOR TREATMENT, IT WAS IMPOSSIBLE TO REMOVE THE RELEASE PAPERS OF THREE (3) IV3000 7X9CM CTN 100. ALL PRODUCTS TESTED FROM THE CARTON WERE AFFECTED. A COMPETITOR'S DRESSING (UNKNOWN PRODUCT) WAS USED FOR THE TREATMENT. NO DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13111848 ↗
• MalfunctionDec 20, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, BEFORE USE A IV3000 7X9CM CTN 100, IT WAS CONFIRMED THERE WAS A BLACK FOREIGN SUBSTANCE ON THE DRESSING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13047049 ↗
• InjuryMay 18, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, DURING TREATMENT WITH IV3000 7X9CM CTN 100. THE DRESSING DID NOT ADHERE TO THE SKIN. IT WAS UNKNOWN HOW THE TREATMENT WAS FINISHED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845883 ↗
• MalfunctionApr 15, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, BEFORE USE, IT WAS CONFIRMED THE NON-WOVEN PART OF THE DRESSING WAS CREASED AND THE ADHESIVE ON THAT PART WAS WEAK. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671053 ↗
• MalfunctionOct 28, 2020Nonstandard Device; Material Integrity Problem; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT DURING SET UP, THE RELEASE PLASTIC (3) OF THE IV3000 BECOMES LOOSE AND THIS CAUSES THE PLASTIC TO WRINKLE SO THE DRESSING CANNOT BE USED. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DRESSING WITH A SHORT DELAY. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10752202 ↗
• MalfunctionOct 2, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING INSPECTION WHEN THE RELEASE PAPER WAS REMOVED, IT WAS CONFIRMED THE FILM HAD NO ADHESIVE, SO THE DRESSING COULD NOT BE USED. UNKNOWN HOW THE PROCEDURE FINISHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10621815 ↗