PORTEX® THORACIC CATHETERS
Received Jul 24, 2019 · Event occurred Jun 24, 2019
Report 3012307300-2019-02945 · MDR key 8822503
Device
Generic name
Thoracic Catheter Insertion Tray
Manufacturer
Smiths Medical Asd; Inc.Catalog number
200/810/200
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
59 YR
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
NO PRODUCT RETURNED WITH INABILITY TO PERFORM INVESTIGATION. HOWEVER, DEFECT WAS CONFIRMED WITH THE PROVIDED PHOTO. RELEVANT DOCUMENTS WERE REVIEWED AND DEEMED ADEQUATE. BASED ON THE INFORMATION PROVIDED THE COMPLAINT WAS CONFIRMED BUT THE ROOT CAUSE FOR THE DEFECT IS UNABLE TO BE DETERMINED.
Description of Event or Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING REMOVAL OF A SMITHS MEDICAL PORTEX® THORACIC CATHETER THE TUBING SNAPPED IN HALF. SUBSEQUENTLY, THE PATIENT WAS TAKEN BACK TO SURGERY TO REMOVE THE RETAINED 5 CM OF CHEST TUBING. IT WAS NOTED TO BE FOUND IN THE MEDIASTINUM. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.