inforMED
MalfunctionBTS

RUSCH BRONCHOPART DLT LEFT, CARINA HOOK

Received Jun 5, 2026 · Event occurred Apr 17, 2026

Report 8040412-2026-00088 · MDR key 25416837

Device

Generic name

Tube, Bronchial (w/wo Connector)

Manufacturer

Teleflex Medical

Model number

IPN047058

Catalog number

116101-000390

Lot number

40E25G2498

Product problems

  • Material Separation

Patient

72 YR · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "DURING INSERTION OF THE CATHETER, THE HOOK BROKE. IT WAS NECESSARY TO REMOVE THE DEVICE AND INSERT ANOTHER CARLENS CATHETER. THERE COULD HAVE BEEN A RISK OF THE PART GOING INTO THE BODY. THE DEVICE IS AVAILABLE FOR INVESTIGATION." ADDITIONAL INFORMATION RECEIVED ON 19 MAY 2026, INDICATED THAT "PATIENT WAS BACK HOME ON (B)(6) 2026, IN STABLE CONDITION. THE HOOK BROKE OFF BUT WAS STILL PARTIALLY ATTACHED TO THE CATHETER. NO MEDICAL INTERVENTION REQUIRED."