inforMED
MalfunctionNWU

VIA PROCEDURE KIT

Received Mar 1, 2024 · Event occurred Jan 30, 2024

Report 1528319-2024-00015 · MDR key 18817561

Device

Generic name

Procedure Kit

Model number

00717380

Catalog number

00717380

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Rash
  • Rash

Narrative

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE NOTICED A RASH ON THEIR ARM WHILE USING A VIA PROCEDURE KIT. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

Additional Manufacturer Narrative

THE USER FACILITY BELIEVED THE EMPLOYEE OBTAINED THE RASH DUE TO LATEX WITHIN THE VIA PROCEDURE KIT. STERIS CONFIRMED THE PRODUCTS IN THE KIT DO NOT HAVE LATEX. DUE TO NO MALFUNCTION OR LATEX PRESENT, THE KIT WAS NOT RETURNED FOR INVESTIGATION. THIS IS THE ONLY REPORTED COMPLAINT REGARDING THIS ISSUE FOR THE VIA PROCEDURE KIT AND IS CONSIDERED AN ISOLATED EVENT. NO FURTHER INVESTIGATION IS REQUIRED. NO OTHER ISSUES HAVE BEEN REPORTED.