Q2 IV EXTENSION SET
Received Nov 28, 2017
Report 1649914-2017-00096 · MDR key 7064304
Device
Product problems
- Break
- 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 FOLLOW MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
A CUSTOMER REPORT RECEIVED STATES THAT THE CLAMPS ON THE EXTENSION SET SIDE TUBING IS FALLING OFF AND AT LEAST 2 SETS HAVE LOST THEIR SIDE CLAMP. THEY HAVE HAD TO OPEN A NEW SET TO RETRIEVE A CLAMP FOR REPLACEMENT OF THE DEFECTIVE CLAMP.
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 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.