EXCELSIOR CLEARSHIELD

Additional Manufacturer Narrative

UPDATE TO D9: IS THIS DEVICE AVAILABLE FOR EVALUATION? UPDATE TO G3: DEVICE EVALUATED BY MANUFACTURER. UPDATE TO H6: TYPE OF INVESTIGATION (B). UPDATE TO H6: INVESTIGATION FINDINGS (C).

Description of Event or Problem

IT WAS REPORTED THAT "BUBBLES HAVE BEEN NOTED TO BE LEFT IN THE SYRINGE AFTER FOLLOWING MEDLINE'S INSTRUCTIONS ON HOW TO PRIME SYRINGE."

Additional Manufacturer Narrative

IT WAS REPORTED THAT "BUBBLES HAVE BEEN NOTED TO BE LEFT IN THE SYRINGE AFTER FOLLOWING MEDLINE'S INSTRUCTIONS ON HOW TO PRIME SYRINGE." THE CUSTOMER SAID THAT "REMOVING BUBBLES HAS NOT BEEN EFFECTIVE" AND THAT THE "BUBBLES THAT CANNOT BE EXPELLED FROM THE SYRINGE ARE LARGER THAN PIN SIZE." THE CUSTOMER STATED THAT "IT TAKES A LOT OF WORK TO GET THE BUBBLES TO EXPEL FROM THE SYRINGE, FORCING YOU TO WASTE 1-3ML OF SALINE AT TIMES." THE CUSTOMER REPORTED THAT "TEAMS HAVE NOT BEEN USING NOTED SYRINGES WITH BUBBLES AND HAVE BEEN OBTAINING PREFILLED SYRINGES THAT ARE STORED ON PAR WALLS." PER THE CUSTOMER "REPORTED SYRINGES HAVE NOT REACHED THE PATIENT." NO ADDITIONAL INFORMATION IS AVAILABLE. 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.