Medical Action Industries 267004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10809160004968), received between May 6, 2025 and Jun 3, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Incompatible” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Positioning Failure

  STAFF REPORTED THAT THE TAPE WAS NOT ADHERING WELL TO PATIENTS, CREATING CONCERN THAT THE IV COULD MIGRATE OR BECOME DISLODGED. ADDITIONAL TAPE WAS REQUIRED TO MAINTAIN SECURE PLACEMENT. SHE RECALLED ONLY A FEW OCCURRENCES, NONE OF WHICH WARRANTED A PATIENT SAFETY ALERT. WHEN ASKED WHETHER PATIENTS MIGHT HAVE HAD LOTION OR OTHER SUBSTANCES ON THEIR SKIN THAT COULD AFFECT ADHESION, THE SITE ACKNOWLEDGED THAT THIS WAS POSSIBLE. AT THIS TIME, STAFF INDICATED THAT THERE IS INSUFFICIENT INFORMATION TO PURSUE FURTHER ACTION, AND THE CONCERN CAN BE CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385065 ↗
• InjuryMay 6, 2025Component Incompatible; Component Incompatible

  CUSTOMER STATES TRANSPORE TAPE DID NOT ADHERE TO THE PATIENT'S SKIN, CAUSING BLEEDING, CATHETER MIGRATION, AND ASSOCIATED COMPLICATIONS. THE CATHETER WAS NOT SECURED ENTIRELY, SITE HAD TO DIVERT TO A NONSTERILE TAPE TO RESOLVE, AND THERE WAS SOME BLEEDING INDICATIVE OF IRRITATION OR CATHETER ISSUE PER CUSTOMER INCIDENT DETAILS. THE ISSUE WAS RESOLVED BY USING A CARTRIDGE TRANSPORT CONTAINER WHICH CAUSED MILD CONTAMINATION. ON (B)(6) 2025, THE CUSTOMER STATED THE ADHESIVE TAPE DOESN¿T HAVE AS GOOD ADHESION AS OTHER KITS PURCHASED BEFORE, THEREFORE, IT IS DIFFICULT TO HAVE A PROPER FITTING OR SECURING OF THE IV CATHETER. AS A SOLUTION, THE MEDICAL TREATMENT WAS TO USE ANOTHER IV KIT. THE DELAY IN PROCEDURE WAS APPROXIMATELY 15 MINUTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21967173 ↗