Q2 IV EXTENSION SET
Received Nov 28, 2017
Report 1649914-2017-00094 · MDR key 7064309
Device
Product problems
- Fluid/Blood Leak
- Split
- Split
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION WHICH IS IN PROGRESS. A FOLLOW MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
A CUSTOMER REPORTED AN ISSUE ENCOUNTERED WITH THE Q2 EXTENSION SET. THE REPORT STATES THAT BLOOD LEAKED FROM THE Q2 PORT FOLLOWING REMOVAL OF THE PIVO. THE NURSE ATTEMPTED TO FLUSH THE Q2 TO STOP THE BLOOD. IT STOPPED WHILE FLUSHING THEN CONTINUED LEAKING. AFTER REPLACING THE Q2 THE LEAKING STOPPED. THERE WERE NO PATIENT COMPLICATIONS RESULTING FROM THE ALLEGED ISSUE.
Additional Manufacturer Narrative
A DHR REVIEW FOR THE COMPLAINT SAMPLE COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER PROVIDED A LOT NUMBER FOR THE DEVICES THEY HAVE IN STOCK BUT IT IS UNKNOWN IF THE COMPLAINT SAMPLE IS FROM THE SAME LOT. AS A PROACTIVE MEASURE, A REVIEW OF THE DHR FOR THAT LOT WAS CONDUCTED AND NO ANOMALIES WERE IDENTIFIED. A 24 MONTH COMPLAINT HISTORY REVIEW WAS ALSO CONDUCTED AND NO SIMILAR COMPLAINT WAS IDENTIFIED. THE COMPLAINT SAMPLE WAS RECEIVED AND TEARING AT THE SLIT OF THE STEM WAS OBSERVED. A LEAK TEST WAS CARRIED OUT AND THE DEVICE FUNCTIONED WITHIN SPECIFICATION. A PIVO LUER WAS REPORTEDLY USED WITH THIS DEVICE WHICH MAY HAVE CAUSED THE TEARING OF THE STEM SLIT. THE IFU FOR THIS DEVICE INCLUDES A CAUTION INSTRUCTING USERS NOT TO USE NEEDLES OR BLUNT CANNULAE WITH THE DEVICE. THE ROOT CAUSE OF THE ALLEGED ISSUE IS NOT MANUFACTURING RELATED AND IS SUSPECTED TO BE RELATED TO USE OF THE PIVO LUER.