IV3000-1-HAND 10X12CM-CARTON OF 50 66024008Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 05000223417406), received between Sep 30, 2020 and May 11, 2026 — classified as 34 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (10 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 62 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Biocompatibility

  IT WAS REPORTED THAT DURING TREATMENT, 12 HOURS IN, SEVERE ITCHING AT THE SITE OF THE DRESSING, AND THERE WAS A RED PATCH AROUND THE PUNCTURE POINT, APPROXIMATELY 2 BY 2 CENTIMETERS IN SIZE. THE DRESSING WAS REMOVED, THE AREA WAS DISINFECTED, AND A NEW DRESSING WAS APPLIED. TWO HOURS LATER, THE REDNESS HAD SPREAD TO ABOUT 5 BY 5 CENTIMETERS. THE DRESSING WAS REMOVED AGAIN, THE AREA WAS DISINFECTED, AND A GAUZE DRESSING WAS APPLIED. SUBSEQUENTLY, THE RED PATCH EXPANDED TO 8 BY 8 CENTIMETERS, WITH SURROUNDING SWELLING AND MULTIPLE BLISTERS RANGING FROM 0.5 TO 1 BY 1 CENTIMETERS. THE CVC CATHETER WAS REMOVED AND A PERIPHERAL VENOUS CATHETER WAS INSERTED INSTEAD. THE PATIENT REPORTED DIFFICULTY BREATHING, AND THE BLOOD OXYGEN SATURATION WAS MEASURED AT 88%. A MASK WAS CHANGED TO PROVIDE OXYGEN, AND ANTI-ASTHMATIC DRUGS WERE ADMINISTERED AS PER THE DOCTOR'S ORDERS. HALF AN HOUR LATER, THE BLOOD OXYGEN SATURATION ROSE TO 95%, AND THE PATIENT'S BREATHING DIFFICULTY IMPROVED. THE BLISTERS WERE PUNCTURED WITH A STERILE SYRINGE, AND A LIGHT YELLOW FLUID WAS SQUEEZED OUT. THE AREA WAS DISINFECTED WITH IODOPHOR, ALLOWED TO DRY, AND THEN COVERED WITH GAUZE. ONE HOUR LATER, THE PATIENT'S BREATHI

  Patient problems: Blister; Erythema; Low Oxygen Saturation; Rash

  MAUDE report 25145006 ↗
• MalfunctionJan 7, 2026Biocompatibility

  IT WAS REPORTED THAT, DURING AN IV FIXATION TREATMENT, THE PATIENT DEVELOPED WELL-DEFINED ERYTHEMA, MILIARY PAPULES, AND SCATTERED SMALL BLISTERS ON THE SKIN AROUND THE CATHETER PLACEMENT, ACCOMPANIED BY OBVIOUS ITCHING AND BURNING SENSATION. THIS ADVERSE EVENT WAS TREATED BY REMOVING THE DRESSING FROM ONE (1) IV3000 1 HAND 10X12CM CTN 50 IMMEDIATELY ACCORDING TO THE DOCTOR'S ADVICE. CLEANED THE AFFECTED AREA WITH PHYSIOLOGICAL SALINE, WAIT FOR IT TO DRY, APPLIED 1ML X 2 DOSES OF DEXAMETHASONE HYDROCHLORIDE INJECTION AND TOOK ORAL ANTIHISTAMINES FOR SYMPTOMATIC TREATMENT, THEN COVERED WITH A LOW SENSITIVITY GAUZE DRESSING. AFTER 3 DAYS, THE PATIENT'S DISCOMFORT SYMPTOMS GRADUALLY IMPROVED.

  Patient problems: Blister; Erythema; Itching Sensation; Skin Burning Sensation

  MAUDE report 23995795 ↗
• InjurySep 8, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER A CATHETER FIXATION, PATIENT STARTED TO EXPERIENCE SEVERELY IRRITATION, AS SHE WAS UNABLE TO TOLERATE ONE (1) DRESSING FROM THE IV3000 1 HAND 10X12CM CTN 50 (DERMATITIS CONTACT). IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS ADDRESSED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Contact Dermatitis

  MAUDE report 22993261 ↗
• MalfunctionJun 5, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING THE SET UP FOR AN IV FIXATION, IT WAS NOTICED THAT MULTIPLE UNITS FROM ONE (1) IV3000 1 HAND 10X12CM CTN 50 HAD DAMAGED SEAL PACKAGING. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155547 ↗
• MalfunctionApr 22, 2025Delivered as Unsterile Product; Incomplete or Missing Packaging; Delivered as Unsterile Product; Incomplete or Missing Packaging

  IT WAS REPORTED THAT, DURING THE SET UP FOR AN IV FIXATION, IT WAS NOTICED THAT THIRTY-SEVEN (37) INDIVIDUAL IV 3000 DRESSINGS FROM ONE (1) IV3000 1 HAND 10X12CM CTN 50 WERE NOT SEALED AFTER THE CUSTOMER OPENED THE PACKAGING BOX. THE TREATMENT WAS CONTINUED USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880186 ↗
• MalfunctionMar 28, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING TREATMENT, WHEN THE TRANSPARENT DRESSING OF THE PATIENT WAS BEING CHANGED, IT WAS NOTICED THAT EVEN THOUGH THE OUTER PACKAGING OF ONE (1) IV3000 1 HAND 10X12CM CTN 50 WAS INTACT, AIR LEAKAGE WAS FOUND WHEN COMPRESSION WAS MADE. TREATMENT WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21725431 ↗
• InjurySep 16, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE ONCOLOGY DEPARTMENT DUE TO A MALIGNANT TUMOR IN THE RIGHT BREAST, ONE (1) IV3000 1 HAND 10X12CM CTN 50 DRESSING WAS GIVEN TO FIX THE PICC TUBE. THE NEXT DAY THE PATIENT REPORTED ITCHING ON THE SKIN AT THE DRESSING AND SLIGHT ECZEMA WAS FOUND. MOMETASONE FUROATE CREAM WAS APPLIED AND THE SKIN WAS COVERED WITH STERILE GAUZE. REPLACE WITH ANOTHER DRESSING.

  Patient problems: Itching Sensation

  MAUDE report 20224914 ↗
• MalfunctionJul 26, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE IV3000 1 HAND 10X12CM CTN 50 PACKAGING IS BROKEN AND COMPROMISED THE STERILITY BEFORE BEING PROVIDED TO THE PATIENTS. THE TREATMENT WAS COMPLETED WITH A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19844559 ↗
• MalfunctionMay 13, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP FOR TREATMENT, IT WAS NOTICED THAT THE OUTER PACKAGING OF ONE (1) DRESSING FROM A IV3000 1 HAND 10X12CM CTN 50 WAS LEAKING. THE TREATMENT WAS COMPLETED WITHOUT ANY DELAY USING A S+N BACK-UP DRESSING. SINCE THIS WAS NOTICED BEFORE TREATMENT, PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296565 ↗
• InjuryApr 19, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, WHEN THE PATIENT WAS GIVEN SEDATION MEDICATION FOR ACUTE GASTROENTERITIS AFTER COMPLETING VENOUS PUNCTURE WITH AN INDWELLING NEEDLE, A IV3000 1 HAND 10X12CM CTN 50 WAS APPLIED TO PREVENT THE NEEDLE FROM FALLING OFF. THE PATIENT EXPERIENCED LOCAL ITCHING AND DISCOMFORT ABOUT 15 MINUTES AFTER APPLYING THE DRESSING AND A MACULOPAPULAR RASH WAS FOUND AT THE DRESSING COVERED AREA AFTER REMOVING THE DRESSING ON HIS OWN. THE PATIENT WAS ADVISED TO BE GIVEN A TOPICAL APPLICATION OF MOMETASONE AND THE RASH DISAPPEARED IN ABOUT 1 HOUR. ON THE SECOND DAY, THE PATIENT RETURNED TO THE CLINIC AGAIN, AND THERE WAS NO OBVIOUS LOCAL RASH OR ITCHING.

  Patient problems: Discomfort; Itching Sensation; Rash

  MAUDE report 19142430 ↗
• MalfunctionJan 30, 2024Loss of or Failure to Bond; Delivered as Unsterile Product; Packaging Problem; Loss of or Failure to Bond; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT DURING SET UP FOR A PICC TREATMENT ONE (1) IV3000 1 HAND 10X12CM CTN 50 WAS FOUND THAT THE PACKING BAG WAS DAMAGED AND THE DRESSING WAS NOT STICKY. THE TREATMENT WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607775 ↗
• InjuryNov 20, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A PATIENT COURSING CHEMOTHERAPY WAS INDICATED FOR PICC TUBE PLACEMENT, TO REDUCE THE INCIDENCE OF PHLEBITIS AND OTHER ADVERSE REACTIONS TO CHEMOTHERAPY INFUSION. ON (B)(6) 2023, AN IV3000 1 HAND 10X12CM CTN 50 ON THE PICC CATHETER WAS EXCHANGED, THE NEXT DAY THE PATIENT'S PICC TUBE FILM WAS FOUND TO HAVE OBVIOUS REDNESS AND SWELLING. SO THE PATIENT'S SKIN WAS TREATED WITH DISINFECTION, WET COMPRESSES OF DEXAMETHASONE SODIUM PHOSPHATE INJECTION, AND DICLOXACILLIN ANTI-ALLERGY.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 18171473 ↗
• MalfunctionSep 5, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, THE OUTER PACKAGING OF ONE (1) IV3000 1 HAND 10X12CM CTN 50 WAS FOUND TO BE UNSEALED BY THE NURSE. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684716 ↗
• InjuryApr 12, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A PATIENT WITH LEUKEMIA NEEDED TO UNDERGO PICC CHEMOTHERAPY, WHICH REQUIRED WEEKLY PICC, IV3000 1 HAND 10X12CM CHANGES, HEPARIN CAP, AND A 0.9% NACL 20ML FLUSH. THE PATIENT WAS TREATED ON (B)(6) 2023, AT APPROXIMATELY 14:30 PM, WHEN THE PATIENT CAME TO THE HOSPITAL FOR A DRESSING CHANGE, IT WAS FOUND THAT THE SKIN IN CONTACT WITH THE DRESSING WAS COVERED WITH SMALL BLISTERS, HAD A YELLOWISH EXUDATE WITH CRUSTS AND THE SKIN WAS RED AND SWOLLEN. A DEXAMETHASONE 5MG INJECTION WAS IMMEDIATELY APPLIED TO THE SKIN AND DISINFECTED WITH 5% POVIDONE-IODINE SOLUTION. A NEW DRESSING WAS PLACED, AND THE PATIENT WAS ADVISED TO VISIT THE DERMATOLOGIST.

  Patient problems: Dry Skin; Skin Inflammation/ Irritation

  MAUDE report 16722465 ↗
• InjuryJan 10, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A RIGHT THORACIC DRAINAGE TUBE WAS PLACED ON THE PATIENT, TWO DAYS LATER THE SKIN AT THE EDGE OF ONE (1) IV3000 1 HAND 10X12CM CTN 50 WAS FOUND RED. THE DRESSING WAS REPLACED, AND FOUR DAYS LATER, BLISTERS WERE SCATTERED AROUND. THE NEXT DAY, THE BLISTERS HAD RUPTURED, THAT SAME DAY, PATIENT UNDERWENT CHEST CT EXAMINATION AND THE PLEURAL EFFUSION WAS REDUCED. THE THORACIC DRAINAGE AND THE FILM WERE REMOVED ACCORDING TO THE DOCTOR'S ADVICE. LYOPHILIZED RECOMBINANT HUMAN ACIDIC FIBROBLAST GROWTH FACTOR FOR EXTERNAL USE WAS APPLIED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 16134889 ↗
• InjuryJan 10, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT DURING WOUND TREATMENT, PATIENT WAS DYING AND MAINTAINED BY MULTIPLE DRUGS. A DEEP VEIN PUNCTURE WAS CARRIED OUT AND THE IV3000 1 HAND 10X12CM CTN 50 WAS APPLIED. THE NEXT DAY, THE NURSE FOUND THAT RICE LIKE BLISTERS OF DIFFERENT SIZES AROUND THE PUNCTURE SITE AND A 2CMX1CM SIZE SKIN WAS BROKEN, AND RED SHALLOW TISSUE COULD BE SEEN. THE AFFECTED AREA WAS DISINFECTED WITH IODOPHOR, REPLACED WITH ALGINATE DRESSING, AND GAVE ALLERGIC MEDICATION. THE WOUND DID NOT DETERIORATE. HOWEVER, DESPITE TREATMENT GAVE TO THE PATIENT, DIED TWO DAYS LATER.

  Patient problems: Blister; Skin Erosion

  MAUDE report 16134382 ↗
• MalfunctionMay 5, 2022Contamination; Contamination

  DURING SET-UP/INSPECTION OF TREATMENT, WHEN A IV3000 1 HAND 10X12CM POUCH WAS OPENED, IT WAS CONFIRMED THERE WAS A DUST-LIKE FOREIGN SUBSTANCE IN IT. TREATMENT WAS COMPLETED, WITHOUT ANY DELAY, WITH A BACKUP. NO INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14292285 ↗
• MalfunctionMar 23, 2022Contamination; Contamination

  IT WAS REPORTED THAT, THE PATIENT CAME TO THE HOSPITAL FOR PICC CATHETER MAINTENANCE DUE TO LUNG MALIGNANT TUMOR. THE NURSE FOUND THAT THERE WAS ONE 4CM LENGTH WHITE HAIR LOCATED ON THE INNER SIDE OF THE IV3000 1 HAND 10X12CM UNTIL THE DRESSING WAS APPLIED TO THE PATIENT. THE TREATMENT CONTINUED WITH A SMITH A NEPHEW BACK UP. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13865636 ↗
• InjuryMar 9, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE IV3000 1 HAND 10X12CM WAS USED TO FIX THE CATHETER. ON THE NEXT DAY, THE PATIENT COMPLAINED OF SKIN PRURITUS AT THE DRESSING SITE. THE NURSE FOUND THAT THE PATIENT HAD SKIN ALLERGY UNDER THE TRANSPARENT DRESSING. THEY REPLACED THE DRESSING FOR THE PATIENT, AND TOOK VITAMIN C AND CALCIUM GLUCONATE DESENSITIZATION TREATMENT ACCORDING TO THE DOCTOR'S ADVICE. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13711303 ↗
• MalfunctionJan 12, 2022Problem with Sterilization; Physical Resistance/Sticking; Problem with Sterilization; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING TREATMENT, 40 DRESSINGS OF IV3000 1 HAND 10X12CM CTN 50 WERE STUCK WITH THE PACKAGE SO STERILITY COULD NOT BE ASSURED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IT CAUSED ANY DELAY. NO HARM TO THE PATIENT WAS REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236917 ↗
• MalfunctionJan 6, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP THE OUTER PACKAGING OF 35 IV3000 1 HAND 10X12CM CTN 50 WERE TOO TIGHTLY SEALED TO ENFORCE STERILITY OPEN. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13180920 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DRESSING WAS USED TO FIX THE PICC TUBE, 5 DAYS LATER THE PATIENT EXPERIENCED SCATTERED RASHES AND BLISTERS WITH PRURITUS ON THE SKIN WHERE THE DRESSING OF A IV3000 1 HAND 10X12CM CTN 5 WAS APPLIED. THIS ADVERSE EVENT WAS TREATED BY ORAL ANTIALLERGIC DRUGS, EXTERNAL APPLICATION OF TRIMETAZIDINE CREAM ON (B)(6) 2021. IT IS UNKNOWN CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Blister; Rash

  MAUDE report 13090553 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT WITH IV3000 1 HAND 10X12CM CTN 50, THE PATIENT COMPLAINED OF PAIN AT THE APPLICATION SITE. AFTER REMOVING THE TRANSPARENT APPLICATION, IT WAS FOUND BLISTERS AND ULCERATION THAT WERE TREATED WITH MEDICATION (DRUG TREATMENT). THE DRESSING WAS SUSPENDED COMPLETELY. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Blister; Ulcer

  MAUDE report 13088092 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING DRESSING TREATMENT ON (B)(6) 2021, THE PATIENT HAD SKIN ITCHING, RASH, NO PAIN, NO BLISTERS AND NO PUS ON THE SECOND DAY AFTER REPLACING THE FILM. THE DRESSING WAS REPLACED AND DISINFECTED WITH LESS IRRITATING DISINFECTANT. AFTER CLEANING THE SKIN AT THE PATCH, IT WAS APPLIED LOCALLY WITH 5ML NORMAL SALINE + 5MG DEXAMETHASONE INJECTION. THE SYMPTOMS DISAPPEARED FOR THREE CONSECUTIVE DAYS.

  Patient problems: Itching Sensation; Rash

  MAUDE report 13047751 ↗
• MalfunctionNov 9, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT , DURING TREATMENT, A DRESSING OF IV3000 1 HAND 10X12CM CTN 50 WAS CREASED AND DETACHED WITH THE BACKING PAPER. TREATMENT WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780435 ↗