RUSCH BRONCHOPART DOUBLE LUMEN LEFT
Received Apr 3, 2026 · Event occurred Mar 5, 2026
Report 8040412-2026-00040 · MDR key 24773775
Device
Generic name
Tube, Bronchial (w/wo Connect
Manufacturer
Teleflex MedicalModel number
IPN047052Catalog number
116100-000350
Lot number
40E25D1974
Product problems
- Break
- Gas/Air Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4)
Description of Event or Problem
IT WAS REPORTED THAT: "LEAKAGE (ON THE RIGHT SIDE) DURING VENTILATION UP TO 2.5 L/MIN (AMV 5.5 L). FAULT (BREAK) DETECTED IN THE MATERIAL, WITHOUT PRIOR TRAUMA. THE PATIENT SUFFERED NO HARM."
Additional Manufacturer Narrative
(B)(4). THE REPORTED ISSUE THAT THE CONNECTOR BROKE WAS CONFIRMED UPON INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE ACTUAL SAMPLE WAS FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED SAMPLE CONFIRMED THAT THE CONNECTOR WAS BROKE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. HOWEVER, THE ROOT CAUSE OF THE DAMAGE COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION, THE EXACT ROOT CAUSE OF THIS REPORTED ISSUE WAS UNDETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.
Description of Event or Problem
IT WAS REPORTED THAT: "LEAKAGE (ON THE RIGHT SIDE) DURING VENTILATION UP TO 2.5 L/MIN (AMV 5.5 L). FAULT (BREAK) DETECTED IN THE MATERIAL, WITHOUT PRIOR TRAUMA. THE PATIENT SUFFERED NO HARM."