InjuryFOS
UNKNOWN NEONATAL
Received Jan 27, 2017
Report 3009211636-2017-00060 · MDR key 6283135
Device
Product problems
- Material Fragmentation
- Occlusion Within Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 1/27/2017. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH AN ENTERAL FEEDING PUMP. THE CUSTOMER REPORTS THAT THE DRESSING WAS BEING REMOVED TO PREPARE FOR NEW UVC PLACEMENT DUE TO THE OLD LINE BEING OCCLUDED AND NOT DRAWING BACK DESPITE CORRECT LOCATION PER X-RAY. THE NURSE NOTICED TWO SEPARATE CATHETERS, THE 5F CATHETER HAD BEEN BROKEN AND SEPARATED INTO TWO PIECES WITH ONE PART REMAINING IN PATIENT. THE LINE WAS CLAMPED AND REMOVED WITH THE CATHETER STILL INTACT.