IV3000-1-HAND 6X7CM-CARTON OF 100 66024007Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 05000223417383), received between Sep 28, 2020 and Jan 13, 2026 — classified as 6 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (17 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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, BEFORE USE IN TREATMENT, THE PACKAGING OF A IV3000 1 HAND 6X7CM CTN 100 IS DAMAGED AND APPEARS TO BE OPEN. THE TREATMENT WAS FINISHED USING AN EQUIVALENT S+N BACK-UP. NO ADDITIONAL INFORMATION IS AVAILABLE CURRENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058203 ↗
• MalfunctionJan 16, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING INFUSION, WHILE IMMOBILIZING WITH AN IV3000 1 HAND 6X7CM CTN 100 DRESSING, THE PACKAGE WAS DISCOVERED TO BE BROKEN AND WAS IMMEDIATELY REPLACED WITH NO HARM TO THE PATIENT. UPON FEEDBACK IT WAS INFORMED THAT THIS MAY HAVE BEEN CAUSED BY STORAGE PROBLEM BY THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521781 ↗
• MalfunctionMar 3, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING USE, THE IV3000 WAS FOUND UNFOLD AND STUCK TOGETHER. IT IS UNKNOWN HOW THE PROBLEM WAS SOLVED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664255 ↗
• MalfunctionFeb 23, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT AN IV3000 1 HAND 6X7CM CTN 100 INFUSION SET TAPE IS UNMANAGEABLE AS THE THIN TOP PIECE OF TAPE COVERING DOES NOT PEEL OFF EASILY. AS WELL, THE TAPE GETS WRINKLED AND STARTS TO PEEL OFF AFTER BATHING. SKIN TAC OR ADDITIONAL STRIPS OF ANOTHER TAPE HAD TO BE USED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584876 ↗
• MalfunctionFeb 4, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT TWO (2) BOXES OF IV 3000 INFUSION SET TAPE ARE UNMANAGEABLE AS THE THIN TOP PIECE OF TAPE COVERING DOES NOT PEEL OFF EASILY. AS WELL, THE TAPE GETS WRINKLE AND STARTS TO PEEL OFF AFTER BATHING. SKIN TAC OR ADDITIONAL STRIPS OF ANOTHER TAPE HAD TO BE USED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13451149 ↗
• MalfunctionDec 1, 2021Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT, DURING TREATMENT, WHEN THE NURSE PULLED OUT THE NEEDLE AN IV3000 1 HAND 6X7CM CTN 100 BROKEN INTO MANY PIECES. SLOWLY TORE OFF THE BROKEN PARTS AND WIPED OFF THE GLUE. IT IS UNKNOWN HOW THE TREATMENT WAS FINISHED. IT IS UNKNOWN IF THERE WAS A THERAPY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908972 ↗
• MalfunctionNov 30, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT, DURING TREATMENT, THE PAPER PART OF THE IV3000 1 HAND 6X7CM, CTN 100 IS NOT SEPARATING EASILY FROM THE PLASTIC FILM PART OF THE DRESSING. IT IS UNKNOWN HOW TREATMENT WAS RESUMED. PATIENT WAS NOT HARMED AS CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12898221 ↗
• MalfunctionSep 29, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE DRESSINGS IN THIS BATCH WAS NOT ADHESIVE ENOUGH EVEN SOME WERE FOUND SEPARATED FROM THE BACKING PAPER WHEN OPENED UP. NO PATIENT HARM REPORTED. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550990 ↗
• MalfunctionSep 29, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE DRESSINGS IN THIS BATCH WAS NOT ADHESIVE ENOUGH EVEN SOME WERE FOUND SEPARATED FROM THE BACKING PAPER WHEN OPENED UP. NO PATIENT HARM REPORTED. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550987 ↗
• MalfunctionSep 28, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE DRESSINGS IN THIS BATCH WAS NOT ADHESIVE ENOUGH EVEN SOME WERE FOUND SEPARATED FROM THE BACKING PAPER WHEN OPENED UP. NO PATIENT HARM REPORTED. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544410 ↗
• MalfunctionSep 28, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE DRESSINGS IN THIS BATCH WAS NOT ADHESIVE ENOUGH EVEN SOME WERE FOUND SEPARATED FROM THE BACKING PAPER WHEN OPENED UP. NO PATIENT HARM REPORTED. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544365 ↗
• MalfunctionSep 28, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE DRESSINGS IN THIS BATCH WAS NOT ADHESIVE ENOUGH EVEN SOME WERE FOUND SEPARATED FROM THE BACKING PAPER WHEN OPENED UP. NO PATIENT HARM REPORTED. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544363 ↗
• MalfunctionSep 1, 2021Loss of or Failure to Bond; Peeled/Delaminated; Loss of or Failure to Bond; Peeled/Delaminated

  IT WAS REPORTED THAT DURING TREATMENT, ONE BOX OF IV3000 1 HAND 6X7CM CTN 100 WON¿T STICK TO THE PATIENT'S SKIN. THE PATIENT USE THEM TO COVER THE INFUSION SITES OF THE INSULIN PUMP. THE PATIENT APPLY THEM AND THEY PEEL OFF WITH THE OVERLAY. A COMPETITORS PRODUCT WAS USE TO SOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410410 ↗
• MalfunctionJun 30, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT IN A IV3000 1 HAND 6X7CM CTN 100 BOX THE BACK LINER WAS SEPARATED FROM THE FILM. THIS PROBLEM WAS PRESENT IN MULTIPLE DRESSINGS FROM THE SAME BOX. NO CASE INVOLVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096703 ↗
• InjuryJun 24, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER INSULIN PUMP THERAPY, THE PATIENT STARTED EXPERIENCING REDNESS AND SKIN STRIPPING ABOUT A COUPLE OF MONTHS AGO. PATIENT USES SKIN-PREP WIPES TO PREPARE FOR CANNULATION SITE AND IV3000 1 HAND 6X7CM TO FIXATE THE CATHETER AND PROTECT INSERTION SITE, SO THIS ADVERSE EVENT COULD HAVE BEEN CAUSED BY EITHER. PATIENT, WHO HAS BEEN USING OUR PRODUCTS FOR ABOUT 20 YEARS, ALSO CLAIMS THAT QUALITY OF SUCH PRODUCTS HAS DECREASED RECENTLY, SO THEY ARE NOT FULFILLING THEIR FUNCTION TO PROTECT SKIN AS THEY SHOULD. IT IS UNKNOWN HOW THE PATIENT HAS BEEN ALLEVIATING/TREATING THE INJURED SKIN.

  Patient problems: Local Reaction; Skin Tears

  MAUDE report 12057851 ↗
• MalfunctionJun 10, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT 40 IV3000 1 HAND 6X7CM CTN 100 OF LOT 2012 WERE TURNED BACK TO DISTRIBUTOR FOR MANY DRESSINGS WERE EMPTY AND CURLED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979888 ↗
• MalfunctionJun 3, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, A IV3000 6CM X 7CM PERIPHERAL CATHETERS CTN 100 IS CURLED. NO OTHER COMPLICATIONS WERE REPORTED; HENCE, NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11933813 ↗
• MalfunctionMay 31, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING TREATMENT, NINETEEN (19) OF IV3000 6X7 PEELED OFF, ARE WRINKLED AND CANNOT BE USED. TREATMENT WAS RESUMED, WITHOUT ANY SIGNIFICANT DELAY, WITH AN AVAILABLE SMITH AND NEPHEW BACK UP DEVICE; THEREFORE, PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11910642 ↗
• MalfunctionMay 27, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE RELEASE COVERING IN STEP 4 WILL NOT RELEASE IN ABOUT 60% OF THE TIME, AND THAT IS FRUSTRATING. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892760 ↗
• MalfunctionMay 26, 2021Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem

  IT WAS REPORTED THAT THE IV3000 1 HAND 6X7CM CTN 100 DRESSING 72 WERE CREASED AND NOT ADHESIVE. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882811 ↗
• MalfunctionMay 11, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, A FEW IV3000 HAD ABOUT A ONE HALF CENTIMETER STRIP ON THE OUTER EDGE HAD NO ADHESIVE SO COULD NOT STICK TO THE SKIN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809679 ↗
• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CVC FIXATION THE PATIENT SHOWED BLISTERS AT THE DRESSING AREA OF A IV3000 6CM X 7CM PERIPHERAL CATHETERS CTN 100. THERE BLISTER WERE CURED BY REMOVING THE FILM AND REPLACING IT WITH GAUZE, AND THE PATIENT WAS DISCHARGED.

  Patient problems: Blister

  MAUDE report 11697973 ↗
• MalfunctionApr 11, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING USE, PATIENT USES THE IV3000 DEVICE FOR HIS CGM AND NOW THAT PATIENT IS ABOUT HALF WAY THROUGH THE BOX THE ADHESIVE IS STICKING TO THE BACKING WHEN PATIENT TRIES TO APPLY IT AND IT SOMETIMES PULLS OUT HIS CGM. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED AND IF THERE WAS A DEALY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646759 ↗
• InjuryFeb 26, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT BEFORE TREATMENT THE DRESSING WAS STICK TO THE LINING, SO THE DRESSING COULD NOT BE USED. A COMPETITOR PRODUCT WAS USED INSTEAD. NO PATIENT HARM REPORTED. IT IS UNKNOWN THE EXACT NUMBER OF DEFECTIVE DRESSINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388832 ↗
• InjuryFeb 23, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT WHEN THE RELEASE PAPER #1 WAS REMOVED, THE FILM WAS LIFTED AND CREASED, SO IT COULD NOT BE USED. SEVERAL DRESSINGS IN THE CARTON WERE CHECKED AND ALL WERE AFFECTED. COMPETITIVE PRODUCTS WERE USED FOR THE TREATMENT. NO DELAY WAS REPORTED. 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 11364880 ↗