DRAINAGE CATHETER
Received Jun 24, 2014 · Event occurred Jun 5, 2014
Report 1319211-2014-00094 · MDR key 3902242
Device
Product problems
- Fracture
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE DISPOSABLE DEVICE HAS BEEN DISPOSED OF BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. AS REPORTED, THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THE EVENT. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION IN REGARDS TO THE EVENT AND THE PATIENT'S WELL-BEING. COMPLAINT #: (B)(4).
Description of Event or Problem
AS REPORTED ON (B)(6) 2014, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR A DRAINAGE CATHETER PLACEMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DRAINAGE CATHETER HAD FRACTURED INSIDE OF THE PATIENT. THE FRACTURED PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THIS EVENT. THE REPORTED DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION AS IT HAS BEEN DISPOSED OF BY THE USER.