LTXFR LGE BORE Y-IRR
Received Nov 27, 2013 · Event occurred Oct 30, 2013
Report 9613251-2013-00299 · MDR key 3723380
Device
Product problems
- Fluid/Blood Leak
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
THE CUSTOMER CONTACT REPORTED A LEAK. THE PIERCING PINS OF THE BIFURCATED TUBING SET WERE TO BE USED TO DELIVER TWO 3000 ML CONTAINERS OF NORMAL SALINE VIA GRAVITY. IT WAS REPORTED THAT DURING PRIMING PRIOR TO PT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE DISTAL END OF ONE OF THE TWO PIERCING PINS OF THE BIFURCATED TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.
Additional Manufacturer Narrative
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.