PORT ACCESS INSERT OUTPNT

Additional Manufacturer Narrative

UPDATE TO D9: SAMPLE NOT RETURNED. UPDATE TO H3: DEVICE NOT EVALUATED. UPDATE TO H6: TYPE OF INVESTIGATION. UPDATE TO H6: INVESTIGATION FINDINGS.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2025 WHEN THE PORT WAS BEING FLUSHED IT WAS IDENTIFIED THAT THE "SYRINGE WING WAS BROKEN AND RIPPED THE NURSE'S GLOVE".

Additional Manufacturer Narrative

IT WAS REPORTED THAT ON (B)(6) 2025 WHEN THE PORT WAS BEING FLUSHED IT WAS IDENTIFIED THAT THE "SYRINGE WING WAS BROKEN AND RIPPED THE NURSE'S GLOVE". 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 (B)(6) 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.