MEDLINE

Additional Manufacturer Narrative

UPDATE TO H6, H7, AND H9. AFTER FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT THE ISSUE WAS RELATED TO A MANUFACTURING PROCESS PROBLEM, RESULTING IN A MANUFACTURING DEFICIENCY. A RECALL WAS INITIATED AND REPORTED TO FDA UNDER REPORT NUMBER R-26-025. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT." AS A RESULT, THE FACILITY STATED THAT OTHER SYRINGES WERE USED FROM THEIR OWN STOCK. THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED ISSUE.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT." AS A RESULT, THE FACILITY STATED THAT OTHER SYRINGES WERE USED FROM THEIR OWN STOCK. THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE 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. DUE TO THE REPORTED PROBLEM/ISSUE, AND IN AN ABUNDANCE OF CAUTION, AN ADVERSE EVENT REPORT WILL BE FILED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.