inforMED
OtherFCE

CLEANSING ENEMA SET

Received Dec 10, 2024 · Event occurred Nov 12, 2024

Report MW5163497 · MDR key 20913491

Device

Generic name

Enema Kit

Patient

80 YR · Male

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Narrative

Description of Event or Problem

RN WAS ADMINISTERING A LACTULOSE ENEMA. AFTER THE ENEMA WAS ADMINISTERED, THE RN REALIZED THAT THE CAP OF THE ENEMA TUBING WAS NOT TAKEN OFF AND WAS INSERTED INTO THE RECTUM. ONCE THE RN NOTICED THE MISTAKE, HE NOTIFIED THE PROVIDER AND THE PROVIDERS CAME TO THE BEDSIDE. THIS PATIENT WENT FOR A SIGMOIDOSCOPY FOR REMOVAL. THE PATIENT RECOVERED WELL FROM THE PROCEDURE. SUBMITTING FOR POTENTIAL CHANGE IN DESIGN FOR CAP SO IT CANNOT BE INSERTED INTO RECTUM.