WNTHRP CPJT HOLDERS 2ML/5ML (F)
Received Sep 20, 2013 · Event occurred Aug 23, 2013
Report 1925262-2013-00001 · MDR key 3410581
Device
Product problems
- Break
Patient
70 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE PT REPORTED DEVICE BREAKAGE. THE PT REPORTED THAT THE CARPUJECT HOLDER WAS BEING USED TO DELIVER HEPARIN SODIUM 5,000U/0.5 ML EVERY 8 HOURS, VIA SELF-ADMINISTERED SUBCUTANEOUS INJECTIONS. ON (B)(6) 2013 AT 0800, IT WAS REPORTED THAT WHILE A PREFILLED MEDICATION CARTRIDGE WAS BEING LOADED INTO THE CARPUJECT HOLDER, THE DEVICE "COLLAPSED" IN THE PT'S HAND. ON (B)(6) 2013, THE PT REPORTED THAT THE HEPARIN THERAPY WAS NOT ADMINISTERED. ON (B)(6) 2013, THE DEVICE WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Additional Manufacturer Narrative
THE PT INDICATED THAT THE DEVICE WAS DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED DEVICE BREAKAGE WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.