Q2 CHECKMATE EXTENSION SET 44 INCH.
Received Mar 1, 2017 · Event occurred Feb 1, 2017
Report 1649914-2017-00014 · MDR key 6368206
Device
Generic name
Intravascular Administration Extension Set
Manufacturer
Quest Medical, Inc.Model number
9541Product problems
- Leak/Splash
- Device Slipped
Patient
Not reported
- Blood Loss
- Blood Loss
Narrative
Additional Manufacturer Narrative
QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem
THE NURSE REPORTED AN ISSUE OCCURRED WITH THE IV ADMINISTRATION EXTENSION SET DURING USE. SHE STATED THE SET LEAKED DURING USE. FOLLOW-UP WITH THE COMPLAINANT FOUND THAT THE TUBING WAS LOOSE AND THE CONNECTOR KEPT ROTATING; IT WAS NOT TIGHTENING. THE REPORT STATED THE PATIENT WAS HIV POSITIVE AND THE LEAK RESULTED IN A LARGE AMOUNT OF BLOOD ON THE FLOOR. THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE WAS DISCARDED BY THE HOSPITAL AND WILL NOT RETURN FOR EVALUATION. ADDITIONAL FOLLOW-UP ATTEMPTS HAVE NOT BEEN SUCCESSFUL.