Q2 IV EXTENSION SET
Received Nov 28, 2017
Report 1649914-2017-00095 · MDR key 7064298
Device
Product problems
- Leak/Splash
- 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 THE DEVICE LEAKED AFTER IT WAS USED WITH A LUER LOCK ACCESS DEVICE TO DRAW BLOOD IN THE ER. THE NURSE REPLACED THE DEVICE WITH A NEW ONE AND THE LEAKAGE 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 AS WELL AS A COLLAPSED STEM WAS OBSERVED. A LEAK TEST WAS CARRIED OUT AND THE DEVICE FUNCTIONED WITHIN SPECIFICATION. A LLAD DEVICE WAS REPORTEDLY USED WITH THE COMPLAINT SAMPLE. A SHARP EDGE ON THE MALE LUER OF THE LLAD MAY HAVE CAUSED THE STEM COLLAPSE OR TEAR OF THE SLIT. SINCE THE LLAD WAS NOT RECEIVED FOR EVALUATION IT IS UNKNOWN IF THIS IS THE ROOT CAUSE OF THE ALLEGED ISSUE. THE ROOT CAUSE IS NOT MANUFACTURING RELATED.