OMNIFLUSH

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY, THE NURSE REPORTED THAT THE SYRINGES LEAVE INK ON THE HANDS AFTER DISINFECTION WITH AN ALCOHOL-BASED HAND RUB, STATING THAT THE HANDS TURNED COMPLETELY BLACK. THE NURSE ALSO REPORTED THAT THE SYRINGES LEAVE BLACK MARKS ON DRY HANDS. THE NURSE FURTHER STATED THAT THEY ARE UNABLE TO VENT THE SYRINGES COMPLETELY, AS AN AIR BUBBLE ALWAYS REMAINS. 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 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 NURSE REPORTED THAT THE SYRINGES LEAVE INK ON THE HANDS AFTER DISINFECTION WITH AN ALCOHOL-BASED HAND RUB, STATING THAT THE HANDS TURNED COMPLETELY BLACK. THE NURSE ALSO REPORTED THAT THE SYRINGES LEAVE BLACK MARKS ON DRY HANDS. THE NURSE FURTHER STATED THAT THEY ARE UNABLE TO VENT THE SYRINGES COMPLETELY, AS AN AIR BUBBLE ALWAYS REMAINS.