InjuryOGJ
ARROW EPIDURAL CATHERIZATION KIT
Received Nov 5, 2014 · Event occurred Oct 25, 2014
Report 1036844-2014-00445 · MDR key 4254142
Device
Product problems
- Material Fragmentation
- Material Separation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Information
- No Code Available
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. ATTEMPT MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY (THAD DUFRENNE - DIRECTOR OF RISK MANAGEMENT; HOWEVER, NO RESPONSE RECEIVED FROM USER FACILITY AT THE TIME OF THIS REPORT.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT DURING THE REMOVAL PROCESS; THE CATHETER BROKE OFF INTO THE PATIENT. THE CUSTOMER, ALSO, ALLEGES THAT THERE WERE FIVE (5) PIECES OF THE CATHETER STUCK IN THE PATIENT. INTERVENTION: THE CATHETER HAD TO BE SURGICALLY REMOVED FROM THE PATIENT.