BAG, ENEMA, SLIDE CLAMP, POLYBAG
Received Jul 24, 2009 · Event occurred Apr 1, 2009
Report 1417592-2009-00040 · MDR key 1422397
Device
Product problems
- Entrapment of Device
- Difficult to Remove
- Improper or Incorrect Procedure or Method
Patient
71 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT A PT IN THE HOSP SETTING WAS SELF ADMINISTERING AN ENEMA AND DID NOT REMOVE THE TUBE TIP PROTECTOR PRIOR TO USE. WHEN THE TUBE WAS REMOVED, THE PROTECTOR REMAINED INSIDE. IT WAS SUBSEQUENTLY REMOVED IN A MEDICAL PROCEDURE UNIT. THERE WAS NO SERIOUS INJURY AND THE PT DID WELL. THIS HAD NOT BEEN REPORTED TO US WHEN THE INCIDENT FIRST OCCURRED. THE TUBING IS CLEAR AND THE TIP PROTECTOR IS A BRIGHT BLUE COLOR. IT IS UNKNOWN WHY THE END USER WAS SELF ADMINISTERING THIS ENEMA AND WE DO NOT KNOW WHAT INSTRUCTIONS WERE PROVIDED BY THE CLINICIAN. NO SERIOUS INJURY RESULTED BUT MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE CAP. THE INCIDENT WAS NOT CAUSED BY A PRODUCT DEFECT BUT RATHER BY MISUSE ON THE PART OF THE END USER. THIS IS A PRESCRIPTION DEVICE AND IS LABELED AS SUCH. IT IS EXEMPT FROM INSTRUCTIONS FOR USE PER 21 CFR 801.109. HOWEVER, WE HAVE TAKEN AN ADDITIONAL MEASURE AND REVISED OUR LABELING TO ADD A CAUTION STATEMENT INDICATING THE TIP PROTECTOR IS TO BE REMOVED PRIOR TO USE.
Description of Event or Problem
IT WAS REPORTED THAT A PT GAVE HIMSELF THE ENEMA WHILE ON THE FLOOR AND HE LEFT THE CAP ON. WHEN HE PULLED IT OUT, THE CAP WAS RETAINED. IT REQUIRED MEDICAL INTERVENTION TO REMOVE THE CAP FROM THE PT.