EXT DIAL-A-FLO SET 18IN PP Y-SITE NDEHP
Received Jan 17, 2014 · Event occurred Jan 1, 2013
Report 9613251-2014-00007 · MDR key 3704528
Device
Product problems
- Inaccurate Delivery
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER CONTACT REPORTED INACCURATE DELIVERY. ON AN UNSPECIFIED DATE, THE TUBING SET WAS BEING USED TO DELIVERY AN UNSPECIFIED MEDICATION, VIA GRAVITY. THE CUSTOMER CONTACT REPORTED THAT THE DIAL-O-FLOW REGULATOR IS NOT RELIABLE WHEN THE NUMBER OF DROPS ARE COUNTED WITH THE NAKED EYE. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED, INCLUDING WHAT THE EXPECTED RATE TO BE DELIVERED WAS VERSUS WHAT THE ACTUAL RATE DELIVERED WAS AND IF THE TUBING SET WAS REPLACED AND THE THERAPY RESUMED.
Additional Manufacturer Narrative
THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.