PORT DRESSING KT

Additional Manufacturer Narrative

IT WAS REPORTED ON (B)(6) 2024 WHEN THE SYRINGE WAS CONNECTED TO THE "CLAVE" AND THE NURSE ATTEMPTED TO FLUSH THE LINE, IT WAS NOTED THAT THE FLUID WAS "LEAKING", AND THE SYRINGE WAS "BROKEN". THE CUSTOMER REPORTED, AFTER THE INCIDENT OCCURRED A NEW DEVICE WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED. THE CUSTOMER REPORTED THERE WAS NO HARM OR IMPACT TO THE PATIENT. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR (B)(4) ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED ON (B)(6) 2024 WHEN THE SYRINGE WAS CONNECTED TO THE "CLAVE" AND THE NURSE ATTEMPTED TO FLUSH THE LINE, IT WAS NOTED THAT THE FLUID WAS "LEAKING", AND THE SYRINGE WAS "BROKEN".

Additional Manufacturer Narrative

UPDATE TO D3: MANUFACTURER FEI REGISTRATION NUMBER: (B)(4).