RUSCH NASOPHARYNGEAL AIRWAY, LATEX FREE
Received Jul 31, 2025 · Event occurred Mar 31, 2025
Report 8040412-2025-00192 · MDR key 22673799
Device
Generic name
Airway, Nasal
Manufacturer
Teleflex Medical Sdn. Bhd.Catalog number
185420-000260
Lot number
KMA21C0058
Product problems
- Packaging Problem
- Packaging Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
QN# (B)(4). THE REPORTED COMPLAINT 'TUBES STICKING TO THE PACKAGING' WAS CONFIRMED THROUGH THE INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED A BOX CONTAINING FIVE UNOPENED PACKAGES OF SAMPLES FOR INVESTIGATION. TWO OF THE SAMPLES WERE OBSERVED TO HAVE CRYSTALLIZATION. A DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED FOR THIS INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, THE COMPLAINT IS CONFIRMED AND VERIFIED TO BE RELATED TO THE MANUFACTURING PROCESS. FURTHER INVESTIGATION HAS BEEN INITIATED UNDER TELEFLEX'S QUALITY SYSTEM BY THE MANUFACTURING SITE TO EVALUATE THIS ISSUE.
Description of Event or Problem
IT WAS REPORTED THAT: "TUBES STICK TO THE PACKAGING".
Additional Manufacturer Narrative
QN#(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT: "TUBES STICK TO THE PACKAGING".