LS LF REG EXT SET NON-DEHP
Received Apr 26, 2013 · Event occurred Apr 1, 2013
Report 9613251-2013-00113 · MDR key 3093471
Device
Product problems
- Fluid/Blood Leak
Patient
NA
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem
THE CUSTOMER CONTACT REPORTED A LEAK. ON AN UNSPECIFIED DATE, THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION. IT WAS REPORTED THAT PRIOR TO PATIENT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. THE TUBING SET WAS RETURNED TO THE PURCHASING MANAGER WITH A NOTE THAT STATED, ¿COMING OUT THROUGH THE BLUE DIAL.¿ NO SPECIFIC DETAILS WERE PROVIDED. THOUGH REQUESTED, NO ADD¿L INFO WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED.