MEDLINE

Additional Manufacturer Narrative

IT WAS REPORTED THAT "REMOVING THE PATIENT'S CATHETER- WITHDREW ALL 10ML OF SALINE, GOT A SECOND SYRINGE, AND DOUBLE-CHECKED THAT I REMOVED IT ALL, THEN PULLED IT. UPON REMOVAL, THERE WAS STILL A SMALL AMOUNT OF SALINE AND/OR AIR LEFT, CAUSING DISCOMFORT TO THE PATIENT AND ULTIMATELY A SMALL AMOUNT OF BLEEDING FROM THE URETHRA". THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE. IT HAS BEEN DETERMINED THAT THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY; HOWEVER, IT MEETS THE DEFINITION OF A REPORTABLE MALFUNCTION, AS RECURRENCE OF THE MALFUNCTION COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.

Description of Event or Problem

SALINE/AIR LEFT IN BALLOON DURING REMOVAL.