SYRINGE, 10ML SALINE IN 10ML

Additional Manufacturer Narrative

CORRECTION TO D3: MANUFACTURER.

Description of Event or Problem

IT WAS REPORTED THAT THE "MALE PIECE" OF THE SODIUM CHLORIDE FLUSH HAD "BROKEN OFF INTO THE CAP" PRIOR TO USE.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE "MALE PIECE" OF THE SODIUM CHLORIDE FLUSH HAD "BROKEN OFF INTO THE CAP" PRIOR TO USE. THE CUSTOMER REPORTED THE PRODUCT WAS NOT USED FOR PATIENT CARE. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. 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.