Q2 CHECKMATE EXTENSION SET
Received Nov 8, 2017 · Event occurred Aug 31, 2017
Report 1649914-2017-00077 · MDR key 7011798
Device
Generic name
Intravascular Administration Set
Manufacturer
Quest Medical, Inc.Model number
9545Catalog number
9545
Lot number
0502535D06
Product problems
- Leak/Splash
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THE ALLEGED ISSUE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A SIMILAR PRODUCT WHICH UNDERGOES THE SAME MANUFACTURING PROCESS AS THE PRODUCT COMPLAINED ABOUT WAS EVALUATED AND NO LEAKAGE WAS OBSERVED. DHR REVIEW CONDUCTED DID NOT IDENTIFY ANY MANUFACTURING ISSUES. THE ROOT CAUSE OF THE ALLEGED DEFECT IS UNKNOWN.
Description of Event or Problem
THE HOSPITAL REPORTED AN ISSUE ENCOUNTERED WITH THE INTRAVENOUS ADMINISTRATION EXTENSION SET DURING USE. THE REPORT STATED THAT WHEN THEY TIGHTEN THE SPIN CONNECTOR ON THE DEVICE IT KEEPS TURNING AND "STRIPS" CAUSING PRODUCT TO LEAK; IT HAS HAPPENED ON MULTIPLE OCCASIONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION.