InjuryPYI
PORTEX THORACIC CATHETERS
Received Aug 24, 2018 · Event occurred Jul 27, 2018
Report 3012307300-2018-03557 · MDR key 7815427
Device
Generic name
Thoracic Catheter Insertion Tray
Manufacturer
Smiths Medical Asd; Inc.Catalog number
200/810/280
Product problems
- Material Fragmentation
- Material Separation
- Material Fragmentation
- Material Separation
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVAL OF A SMITHS MEDICAL PORTEX¿ THORACIC CATHETER RESISTANCE WAS MET. AS THE DOCTOR PROCEEDED TO PULL OUT THE CATHETER, IT SNAPPED; LEAVING PARTS OF THE CATHETER INSIDE THE PATIENT. SUBSEQUENTLY, THE PATIENT WAS REQUIRED TO GO TO THE OPERATING ROOM (OR) FOR REMOVAL OF THE RETAINED PARTS. THE PATIENT RECOVERED WITH NO FURTHER ADVERSE EFFECTS.