PERICARDIOCENTESIS KIT
Received Mar 25, 2025 · Event occurred Mar 18, 2025
Report 1125782-2025-00003 · MDR key 21694165
Device
Generic name
Fluid Drainage Tray
Manufacturer
Merit Medical Systems, Inc.Catalog number
PC101/JPB
Lot number
T3088168
Product problems
- Fracture
- Material Integrity Problem
- Fracture
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED. THE CATHETER SHAFT HAD SEPARATED FROM THE STRAIN RELIEF, BUT THE CATHETER TIP WAS FOUND TO BE INTACT ON THE CATHETER BODY. THE SEPARATION OCCURRED TO MISALIGNMENT OF THE CATHETER PARTS DURING MOLDING. 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.
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE ACCOUNT ALLEGES THAT THE CATHETER DETACHED FROM THE JUNCTION WITHIN THE PATIENT. THE TIP WAS RETRIEVED.