MalfunctionOFD
INTRO-FLEX INTRODUCER 8.5F
Received May 16, 2025 · Event occurred Apr 6, 2025
Report 1417592-2025-00230 · MDR key 22036785
Device
Generic name
Intro-flex Introducer 8.5f
Manufacturer
Medline Industries LpCatalog number
I500F85C
Lot number
2024091090
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
68 YR · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE SHEATH/KIT AND SWAN HAD TO BE REPLACED .IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
"SWAN SLEEVE WAS FAULTY"