inforMED
MalfunctionGCE

SPRAY CATHETER

Received Dec 30, 2024 · Event occurred Oct 20, 2024

Report 21034612 · MDR key 21034612

Device

Generic name

Adaptor, Catheter

Model number

WP-18/2200

Lot number

M230925311

Patient

2 MO · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

3-D MATRIX PURASTAT SPRAY CATHETER LOT# M230925311, REF# (B)(6) ADAPTER APPLIED TO PURASTAT GEL SYRINGE AND SPRAY CATHETER AND PURASTAT GEL INJECTED INTO CATHETER SYRINGE THEN DISCONNECTED AND FILLED WITH AIR AS IFU INSTRUCTS. AFTER SYRINGE APPLIED BACK ONTO SPRAY CATHETER TO DELIVER THE GEL FROM THE CATHETER IT WAS FOUND TO HAVE NO GEL EXPELLING CATHETER. UPON FURTHER EXAMINATION IT APPEARED THAT BLUE CONNECTION PORT ON SPRAY CATHETER WAS CRACKED WHICH KEPT THE PRODUCT FROM DISPENSING.