LS LF REG EXT SET NON-DEHP
Received Nov 7, 2015 · Event occurred Mar 1, 2014
Report 9613251-2015-00064 · MDR key 5209494
Device
Generic name
80fpk
Manufacturer
Hospira, Ltd Reg No: 9613251Model number
NACatalog number
20667
Lot number
340324W
Product problems
- Material Separation
Patient
Unknown
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ONE USED DEVICE WAS RECEIVED ON 04/02/2014 AND EVALUATED. TESTING FOUND THE TUBING SEPARATED FROM THE OUTLET PORT OF THE DIAL-A-FLO ASSEMBLY OF THE TUBING SET. THIS WAS DUE TO INSUFFICIENT SOLVENT APPLICATION. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. UPON FDA REQUEST, THIS REPORT IS BEING SUBMITTED TO REPORT THE CORRECT MFR NUMBER.
Description of Event or Problem
THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF VANCOMYCIN. AFTER AN UNSPECIFIED LENGTH OF TIME AFTER THE DELIVERY WAS STARTED, THE CUSTOMER CONTACT REPORTED THAT THE TUBING SEPARATED FROM THE OUTLET PORT ON THE DIAL-A-FLO ASSEMBLY OF THE TUBING SET AND AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTS OF ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THE PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.