PERCARDIOCENTESIS KIT.STERILE
Received Mar 16, 2022 · Event occurred Mar 2, 2022
Report 1125782-2022-00003 · MDR key 13778738
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.
Description of Event or Problem
THE ACCOUNT ALLEGES THAT THE DEVICE DIDN'T ADEQUATELY DRAIN THE FLUID FROM THE PATIENT'S PAERICARDIAL SACK DURING THE PROCEDURE. THE DEVICE WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.