inforMED
MalfunctionFPK

MNBR EXT 59IN NDHP

Received Mar 25, 2013 · Event occurred Feb 1, 2013

Report 9613251-2013-00082 · MDR key 3034905

Device

Generic name

80fpk

Manufacturer

Hospira Ltd.

Model number

NA

Catalog number

14699

Lot number

22064NS

Product problems

  • Break

Patient

NA

  • No Patient Involvement

Narrative

Description of Event or Problem

THE CUSTOMER CONTACT REPORTED A BROKEN TUBING SET. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION. IT WAS REPORTED THAT PRIOR TO PATIENT USE, THE TUBING SET WAS REPORTEDLY BROKEN IN HALF AT AN UNSPECIFIED LOCATION ON THE TUBING SET. NO SPECIFIED EVENT DETAILS WERE PROVIDED. ALTHOUGH THERE WAS POTENTIAL FOR A LEAK, NO LEAKAGE WAS REPORTED. THOUGH REQUESTED, 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.