FDA Adverse Event Malfunction Summary report: N

BAG, ENEMA FLIP TOP DRY

MDR report key: 1398271 · Received May 15, 2009

Report

Report Number
1398271
Event Type
Malfunction
Date Received
May 15, 2009
Date of Event
April 1, 2009
Report Date
May 15, 2009
Manufacturer
MEDLINE
Product Code
FGD
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PATIENT TOLD RISK MANAGEMENT GAVE HIMSELF THE ENEMA WHILE ON THE FLOOR AND HE LEFT THE CAP ON, WHEN HE PULLED IT OUT, THE CAP WAS NOT ON AND HE TOLD THE NURSE. PATIENT WAS PROVIDED THE SUPPLIES AND INSTRUCTIONS.ADDITIONAL INFO OBTAINED FROM THE SITE:CAP WAS LEFT INSIDE THE PATIENT AND CAP EXTRACTEDIN MEDICAL PROCEDURE UNIT (MPU).WE HAD A SIMILAR REPORT IN JANUARY 4TH OF 2009.ALL OF ENEMA KITS FROM MEDLINE PACKAGING LACKS INSTRUCTIONS TO REMOVE THE (DARK BLUE) END CAP PRIOR TO INSERTION. WE HAVE SWITCHED OUR PRODUCTS FROM MEDLINE ( DYND70102) TO MEDICHOICE (ENBG1500), THE PRODUCT FROM MEDICHOICE HAS CLEARER DIRECTIONS.====================== MANUFACTURER RESPONSE FOR BAG, ENEMA FLIP TOP DRY, BAG, ENEMA FLIP TOP DRY======================WORKING ON ADDING INSTRUCTIONS TO REMOVE THE (DARK BLUE) END CAP PRIOR TO INSERTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BAG, ENEMA FLIP TOP DRY CATHETER, RETENTION, BARIUM ENEMA WITH BAG FGD MEDLINE NA NA

Patients

Seq Age Sex Outcome Treatment
1 71 YR