MEDLINE

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.

Additional Manufacturer Narrative

UPDATED H6: INVESTIGATION FINDINGS (C). UPDATED H6: INVESTIGATION CONCLUSIONS (D). UPDATED H7: IF REMEDIAL ACTION INITIATED, CHECK TYPE. UPDATED H9: IF ACTION REPORTED TO FDA UNDER 21 USC 360I(G), LIST CORRECTION/REMOVAL REPORTING NUMBER.