NDHP LS MICRBR CLAVE
Received Mar 17, 2014 · Event occurred Jan 1, 2014
Report 9613251-2014-00063 · MDR key 3832599
Device
Product problems
- Sticking
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER CONTACT INDICATED THE DEVICE WERE DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED SILICONE SLEEVE OF THE CLAVE PORTS REMAINED IN THE DEPRESSED POSITION WERE IDENTIFIED. THE DEVICES WERE 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 INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem
GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF THE SILICONE SLEEVE OF THE CLAVE PORT ON EXTENSION TUBING SETS REMAINED IN THE DEPRESSED POSITION. ON UNSPECIFIED DATES, THE CUSTOMER CONTACT REPORTED THAT THE SILICONE SLEEVE OF THE CLAVE PORT ON EXTENSION TUBING SETS REMAINED IN THE DEPRESSED POSITION. NO SPECIFIC DETAILS WERE PROVIDED. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.