Q2 IV EXTENSION SET
Received Apr 18, 2019
Report 1649914-2019-00022 · MDR key 8529088
Device
Product problems
- Unintended Movement
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION AND NO LOT NUMBER WAS PROVIDED. A DHR REVIEW COULD NOT BE CONDUCTED WITHOUT THE LOT NUMBER. A SIMILAR PRODUCT WAS PULLED FROM QUEST'S INVENTORY AND THE SAMPLES WERE TESTED. THE REPORTED COMPLAINT CONDITION OF MEDIA SHOOTING OUTSIDE THE TUBING COULD NOT DUPLICATED. THE ROOT CAUSE OF THE REPORTED COMPLAINT IS UNKNOWN. A POSSIBLE ROOT CAUSE MAY BE IMPROPER CLAMPING OF THE TUBING BY THE END USER. QUEST WILL CONTINUE TO MONITOR TRENDS FOR THE REPORTED COMPLAINT CONDITION.
Description of Event or Problem
THE REPORT RECEIVED STATES THAT THE CLAMPS ON THE EXTENSION SETS DO NOT HOLD TIGHTLY AND CAUSES CONTRAST DYE TO SHOOT OUT SIDE TUBING. MULTIPLE PATIENTS HAVE HAD TO RECEIVE DOUBLE DOSES OF CONTRAST MEDIA TO COMPLETE STUDIES AND OTHER MEANS OF CLAMPING THE TUBING HAVE HAD TO BE USED TO PREVENT THE ISSUE FROM HAPPENING. THERE WERE NO REPORTED PATIENT COMPLICATIONS RESULTING FROM THE ALLEGED ISSUE.