inforMED
MalfunctionFCE

*

Received Sep 18, 2014 · Event occurred Sep 15, 2014

Report 4112792 · MDR key 4112792

Device

Generic name

Kit, Enema, (for Cleaning Purpose)

Manufacturer

Medline Industries

Model number

*

Catalog number

DYND70104

Lot number

*

Product problems

  • Break

Patient

*

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

RN PREPARED ENEMA SOAP AND WATER IN THE BUCKET; AS SOON AS SHE HUNG IT THE HANDLE SNAPPED AND BROKE. SHE GOT A SECOND BUCKET FROM AN UNOPENED CASE AND THE SAME THING HAPPENED.