MEDLINE

Additional Manufacturer Narrative

IT WAS REPORTED THAT "THE SYRINGE CRACKED AT THE HUB CONNECTION SITE" AFTER "FLUSHING THE PATIENT'S IV LINE USING A PREFILLED SYRINGE SUPPLIED IN THE PORT ACCESS KIT." THE CUSTOMER REPORTED THAT THEY "ATTACHED A NEW PREFILLED SYRINGE FROM THE SAME KIT TO CONTINUE FLUSHING THE LINE" AND THAT "AFTER COMPLETING THE FLUSH AND REMOVING THE SECOND SYRINGE, THAT SYRINGE ALSO CRACKED AT THE HUB CONNECTION SITE." THE CUSTOMER STATED, "A SMALL FRAGMENT OF PLASTIC FROM THE SYRINGE TIP HAD REMAINED WITHIN THE IV HUB" WHICH "COMPROMISED THE INTEGRITY OF THE CONNECTION, ALLOWING BLOOD BACKFLOW FROM THE PATIENT'S IV LINE." PER THE CUSTOMER, THE "ENTIRE IV LINE WAS REMOVED AND A NEW LINE WAS INITIATED." THE CUSTOMER SAID THAT "THE PATIENT REMAINED STABLE THROUGHOUT THE EVENT WITH NO REPORTED DISCOMFORT OR ADVERSE SYMPTOMS." NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. 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 CFN 1417592 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 THAT "THE SYRINGE CRACKED AT THE HUB CONNECTION SITE" AFTER "FLUSHING THE PATIENT'S IV LINE USING A PREFILLED SYRINGE SUPPLIED IN THE PORT ACCESS KIT." THE CUSTOMER REPORTED THAT THEY "ATTACHED A NEW PREFILLED SYRINGE FROM THE SAME KIT TO CONTINUE FLUSHING THE LINE" AND THAT "AFTER COMPLETING THE FLUSH AND REMOVING THE SECOND SYRINGE, THAT SYRINGE ALSO CRACKED AT THE HUB CONNECTION SITE." THE CUSTOMER STATED, "A SMALL FRAGMENT OF PLASTIC FROM THE SYRINGE TIP HAD REMAINED WITHIN THE IV HUB" WHICH "COMPROMISED THE INTEGRITY OF THE CONNECTION, ALLOWING BLOOD BACKFLOW FROM THE PATIENT'S IV LINE." PER THE CUSTOMER, THE "ENTIRE IV LINE WAS REMOVED AND A NEW LINE WAS INITIATED."