MalfunctionFPK
NDEHP MICR YTYPE CLV
Received Mar 18, 2015 · Event occurred Mar 1, 2015
Report 9613251-2015-00028 · MDR key 4620455
Device
Product problems
- Material Separation
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
THE CUSTOMER CONTACT REPORTED A SEPARATION. IT WAS REPORTED THAT THE CUSTOMER "TESTED" THE TUBING SET BY APPLYING MINIMAL TENSION BETWEEN THE LEG OF THE Y-CONNECTOR AND TUBING. AT THAT TIME, THE TUBING SEPARATED FROM THE LEG OF THE Y-CONNECTOR. THERE WAS NO REPORTED ADVERSE EFFECT OR DELAY OF THERAPY TO ANY PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.