MEDLINE

Additional Manufacturer Narrative

IT WAS REPORTED THAT UPON DEFLATION OF A CATHETER, "THERE WAS STILL A TINY AMOUNT OF AIR INFLATED IN THE BALLOON". THE CUSTOMER CONTACT REPORTED, "CONNECTED A STERILE SYRINGE TO THE BALLOON PORT AND ALLOWED 9.5ML TO NATURALLY BACKFLOW INTO THE SYRINGE. THEN PULLED BACK WITH THE SYRINGE TO DOUBLE-CHECK IF THERE WAS ANY MORE AIR OR WATER LEFT IN THE BALLOON. PULLED BACK 2 ADDITIONAL TIMES TO VERIFY THERE WAS NOTHING LEFT IN THE BALLOON. CATHETER PULLED OUT WITH NO RESISTANCE. WHEN IT WAS COMPLETELY OUT, THERE WAS STILL A TINY AMOUNT OF AIR INFLATED IN THE BALLOON. PT BLED FROM HIS URETHRA FOR A FEW MINUTES AFTERWARDS AND THEN RESOLVED". 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

IT WAS REPORTED THAT UPON DEFLATION OF A CATHETER, "THERE WAS STILL A TINY AMOUNT OF AIR INFLATED IN THE BALLOON".