inforMED
MalfunctionFCE

RITE AID DELUXE COMBINATION SYRINGE

Received Oct 29, 1996 · Event occurred Jul 4, 1996

Report 1528738-1996-00018 · MDR key 47194

Device

Generic name

78 Fce Kit, Enema

Model number

2673-02

Catalog number

NA

Lot number

UNK

Product problems

  • Tip breakage

Patient

94 YR

  • Obstruction/Occlusion

Narrative

Description of Event or Problem

PT WAS USING THE DEVICE WHEN THE SYRINGE PIPE BROKE OFF AND BECAME LODGED IN THE RECTUM. THE PT WAS TRANSPORTED TO THE HOSP FOR REMOVAL. THE PT WAS X-RAYED TO LOCATE THE PIPE. IT WAS REMOVED NONSURGICALLY, AND THE PT WAS SENT HOME THAT DAY. PT IS DOING FINE. THERE WAS NO ILLNESS, INJURY OR MEDICAL INTERVENTION RESULTING FROM THE EVENT. ONE PT INVOLVED.