INTRODUCER,STD,INTRO-FLEX 8.5F,NL
Received Sep 3, 2021 · Event occurred Aug 1, 2021
Report 1038445-2021-00012 · MDR key 12421255
Device
Generic name
Introducer,std,intro-flex 8.5f,nl
Manufacturer
Medline Industries Inc.Catalog number
I550BF85NL
Product problems
- Material Twisted/Bent
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE INTRODUCER BENT WHILE INSIDE OF A PATIENT. DESPITE MULTIPLE GOOD FAITH ATTEMPTS THE REPORTING FACILITY WAS UNABLE OR UNWILLING TO PROVIDE ADDITIONAL INFORMATION TO THE MANUFACTURER. NO FURTHER DETAILS RELATED TO THE INCIDENT ARE KNOWN AT THIS TIME. NO SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AND A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE INTRODUCER BENT WHILE INSIDE OF A PATIENT.