inforMED
MalfunctionFCE

GENT-L-KARE

Received Jul 22, 2021 · Event occurred Jan 23, 2021

Report 12210366 · MDR key 12210366

Device

Generic name

Enema Kit

Product problems

  • Improper or Incorrect Procedure or Method

Patient

12045 DA

  • Pain
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Pain
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

OB (OBSTETRICS) PATIENT DEVELOPED ILEUS POST C-SECTION AND REQUIRED AN ENEMA. THE INSTRUCTIONS HAD BECOME SEPARATED FROM THE KIT AND THE RELATIVELY NEW NURSE, DID NOT REALIZE THAT THE END OF THE TUBING WAS A BLUE COLORED CAP. RATHER, SHE BELIEVED THIS WAS SOMETHING TO MEASURE THE AMOUNT THAT SHOULD BE INSERTED. THE CAP BECAME LODGED IN THE PATIENT'S RECTUM AND COULD NOT BE REMOVED MANUALLY. GI WAS CONSULTED AND REMOVED THE CAP VIA FLEXIBLE SIGMOIDOSCOPY. THE PATIENT COMPLAINED OF PAIN PRIOR TO REMOVAL, BUT HAD NO SIGNIFICANT SEQUALAE. RECOMMENDATION: DISTINGUISH THE CAP BY COLOR, TEXT DIRECTLY ON IT, OR OTHER MEANS, AS A WAY TO HIGHLIGHT THAT THIS IS AN ITEM TO BE REMOVED.