PORTEX
Received Sep 14, 2022
Report 3012307300-2022-19053 · MDR key 15416858
Device
Generic name
Tracheotomy Care Kit
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE KIT CONTAINED PURPLE TRACHEOSTOMY INDUCER THAT DOES NOT CORRECTLY FIT OVER THE GUIDING CATHETER. IT WAS NOT ABLE TO THREAD ALL THE WAY TO THE SAFETY STOP MARK. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
MANUFACTURING SITE ADDRESS IS UNKNOWN. CATALOG NUMBER IS UNKNOWN. UDI INFORMATION IS UNKNOWN. PREMARKET (510K) NUMBER IS UNKNOWN. NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).