MEDLINE

Additional Manufacturer Narrative

UPDATE TO H6, H7, AND H9. AFTER FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT THE DEVICE WAS NOT RETURNED, AND THE INVESTIGATION INVOLVED AN ANALYSIS OF PRODUCTION RECORDS. THE INVESTIGATION IDENTIFIED A MANUFACTURING PROCESS PROBLEM, AND THE INVESTIGATION CONCLUDED THAT A MANUFACTURING DEFICIENCY OCCURRED RELATED TO RECALL R-26-025. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE "SYRINGE KEPT FALLING OFF THE MANIFOLD." PER THE CUSTOMER, THE "MANIFOLD WAS REPLACED AND IT WAS STILL FALLING OFF AND SO THE SYRINGE WAS REPLACED AND IT KEPT IN PLACE." 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 (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

IT WAS REPORTED THAT THE "SYRINGE KEPT FALLING OFF THE MANIFOLD." PER THE CUSTOMER, THE "MANIFOLD WAS REPLACED AND IT WAS STILL FALLING OFF AND SO THE SYRINGE WAS REPLACED AND IT KEPT IN PLACE."