InjuryGCD
BLAKE CHANNEL DRAIN (15FR SILICONE)
Received Apr 22, 2019 · Event occurred Apr 9, 2019
Report MW5086056 · MDR key 8540875
Device
Generic name
Introduction Drainage Catheter And Accessories
Manufacturer
Cardinal Health 200, LlcModel number
JP2188Product problems
- No Device Output
- Material Separation
Patient
57 YR
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
PT AS ONE WEEK POSTOP WITH DRAIN PLACEMENT. TWO DAYS PRIOR TO EVENT, SHE NOTED A CHANGE IN THE CHARACTER OF THE SUCTION OF THE DRAIN AND A STOP IN OUTPUT. WHEN THE DRAIN WAS REMOVED IN THE OFFICE, IT WAS CLEAR THAT A PORTION OF IT WAS SEPARATED AND STAYED BEHIND. AN X-RAY WAS PERFORMED AND AN ATTEMPT TO RETRIEVE THE SEPARATED PORTION WAS DONE BUT SURGERY WAS REQUIRED TO REMOVE THE RETAINED PORTION OF DRAIN. FDA SAFETY REPORT ID# (B)(4).