PORT ACCESS KIT

Additional Manufacturer Narrative

ACCORDING TO FACILITY ON (B)(6) 2025 ONE OF THE SYRINGES IN THE KIT WAS MISSING MARKINGS, LABELS, AND WRITING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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 (B)(6) 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

ACCORDING TO FACILITY ON (B)(6) 2025 ONE OF THE SYRINGES IN THE KIT WAS MISSING MARKINGS, LABELS, AND WRITING.