MEDLINE

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY, "THE RING GRIP SYRINGE KEEPS "UNTWISTING" FROM THE MANIFOLD. WE THREW OUT THE RING GRIP SYRINGE FOR A NEW ONE WITHOUT ANY CHANGE. JUST LETTING THE SYRINGE FILL WITH SALINE WAS ENOUGH PRESSURE TO DISCONNECT IT. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT". THERE WAS NO FURTHER INFORMATION. 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

ACCORDING TO THE FACILITY, "THE RING GRIP SYRINGE KEEPS "UNTWISTING" FROM THE MANIFOLD. WE THREW OUT THE RING GRIP SYRINGE FOR A NEW ONE WITHOUT ANY CHANGE".