BAG, ENEMA, SLIDE, CLAMP, POLYBAG
Received Apr 21, 2009 · Event occurred Feb 18, 2009
Report 1417592-2009-00028 · MDR key 1368451
Device
Product problems
- Entrapment of Device
- Difficult to Remove
- Improper or Incorrect Procedure or Method
Patient
27 YR
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A NURSE DID NOT REMOVE THE TIP FROM THE ENEMA TUBING AND INSERTED IT INTO A PATIENT. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE TIP.
Additional Manufacturer Narrative
ON 3/20/2009 WE WERE MADE AWARE OF AN INCIDENT WHICH OCCURRED IN (B) (6). IT WAS REPORTED THAT AN ENEMA WAS TO BE ADMINISTERED. THE TIP WAS NOT REMOVED BY THE CLINICIAN PRIOR TO INSERTION AND INITIATION OF THE ENEMA. WHEN THE PATIENT COMPLAINED OF PAIN AND UNABLE TO TOLERATE THE PROCEDURE, THE ENEMA TUBING WAS REMOVED AND THE TIP WAS RETAINED. SURGICAL INTERVENTION WAS REQUIRED FOR REMOVAL OF THE TIP. PRODUCT FROM STOCK WAS EVALUATED. THE TUBING IS CLEAR AND THE PROTECTIVE CAP COVERING THE LUBRICATED TUBING TIP IS A BRIGHT BLUE COLOR. THE CLINICIAN SHOULD HAVE KNOWN THE CAP WAS TO BE REMOVED. IT WOULD HAVE ALSO BEEN NOTED WHEN THE TUBING WAS BEING PRIMED AS THE FLUID WOULD BE COMING OUT AROUND THE SIDES OF THE CAP AND NOT OUT THE END. THIS IS AN OBVIOUS MISUSE OF THE PRODUCT. THIS IS NOT A PRODUCT QUALITY ISSUE BUT RATHER A CASE OF MISUSE. HOWEVER, DUE TO THE REPORT INCIDENT REQUIRING SURGICAL INTERVENTION, THIS MEDWATCH IS BEING FILED.