Q2 IV EXTENSION SET
Received Nov 28, 2017
Report 1649914-2017-00098 · MDR key 7064316
Device
Product problems
- Component Falling
- Loose or Intermittent Connection
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. A DHR/PROCESS REVIEW WILL BE CONDUCTED AND A FOLLOW MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
A CUSTOMER REPORT RECEIVED STATES THAT THE WHITE CLAMPS ON THE EXTENSION SETS HAVE BEEN VERY LOOSE AND HAVE BEEN FALLING OFF. THE REPORT ALSO STATES THAT THE STAFF HAVE HAD TO CLAMP THE TUBING SO THERE IS NO CHANCE FOR COMMUNICATION FROM ANY SALINE OR SOLUTION LEFT IN THE TUBING BEING DRAWN BACK AND IN CASES WITH IV FLUID RUNNING THE STAFF HAVE HAD TO DISCONNECT THE FLUIDS. THERE WERE NO REPORTED PATIENT COMPLICATIONS RESULTING FROM THE ALLEGED ISSUE.
Additional Manufacturer Narrative
THE COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION. A DHR REVIEW WAS CONDUCTED AND NO ANOMALIES WERE FOUND. A SAMPLE OF THE DEVICE FROM EXISTING INVENTORY AT QUEST WAS EVALUATED AND THE SLIDE CLAMP WAS INSPECTED AND WAS FOUND TO BE WITHIN SPECIFICATIONS. THE ROOT CAUSE OF THE ISSUE COMPLAINED ABOUT IS UNKNOWN. AS A PROACTIVE MEASURE, A CAPA HAS BEEN INITIATED TO EVALUATE THE EFFECT OF POSSIBLE ALTERNATE CLAMP STYLES THAT MAY BE USED ON THE DEVICE.