BAG,ENEMA,W/SLIDE CLAMP,POLYBAG

Additional Manufacturer Narrative

UPDATE TO H6: INVESTIGATION FINDINGS. UPDATE TO H6: INVESTIGATION CONCLUSIONS.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 WHEN ADMINISTERING A "COTTON SEED OIL ENEMA" THE "BLUE ENEMA CAP" WAS NOT REMOVED PRIOR TO INSERTION AND NOTED TO BE INSIDE THE PATIENT'S RECTUM.

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 WHEN ADMINISTERING A "COTTON SEED OIL ENEMA" THE "BLUE ENEMA CAP" WAS NOT REMOVED PRIOR TO INSERTION AND NOTED TO BE INSIDE THE PATIENT'S RECTUM. THE CUSTOMER REPORTED THE CAP WAS UNABLE TO BE DIGITALLY REMOVED, AND THE PATIENT REQUIRED A "FLEXIBLE SIGMOIDOSCOPY TO REMOVE ENEMA CAP". NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.