ADJUSTABLE FLANGE AIRWAY - 22 FR
Received Dec 24, 2025 · Event occurred Dec 3, 2025
Report 8040412-2025-00276 · MDR key 23887393
Device
Generic name
Airway, Nasopharyngeal
Manufacturer
Teleflex Medical Sdn. Bhd.Catalog number
18542022
Lot number
KMA22E0374
Product problems
- Tear, Rip or Hole in Device Packaging
- Tear, Rip or Hole in Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
Description of Event or Problem
IT WAS REPORTED THAT: "GREEN NASAL TRUMPETS BEGAN TURNING BLACK AND PACKAGING WAS COMPROMISED, TEARING APART WITH THE SLIGHTEST TOUCH. PARTS OF PRODUCT THAT CHANGED COLOR ALSO HARDENED WHICH REDUCED THE FLEXIBILITY OF THE TUBE." ASSOCIATED COMPLAINTS (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT: "GREEN NASAL TRUMPETS BEGAN TURNING BLACK AND PACKAGING WAS COMPROMISED, TEARING APART WITH THE SLIGHTEST TOUCH. PARTS OF PRODUCT THAT CHANGED COLOR ALSO HARDENED WHICH REDUCED THE FLEXIBILITY OF THE TUBE". ASSOCIATED COMPLAINTS 8040412-2025-00143, 8040412-2025-00144, 8040412-2025-00275, AND 8040412-2025-00145.
Additional Manufacturer Narrative
(B)(4).