MEDLINE

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE "SYRINGE WAS UNSCREWING FROM MANIFOLD." THE CUSTOMER REPORTED A NEW REPLACEMENT SYRINGE WAS OPENED AND "ALSO UNSCREWED." PER THE CUSTOMER, AN ADDITIONAL REPLACEMENT SYRINGE WAS OPENED AND "WORKED." DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 WAS UNSCREWING FROM MANIFOLD." THE CUSTOMER REPORTED A NEW REPLACEMENT SYRINGE WAS OPENED AND "ALSO UNSCREWED." PER THE CUSTOMER, AN ADDITIONAL REPLACEMENT SYRINGE WAS OPENED AND "WORKED."