BRILLANT SILICONE 2W 1.5ML PAED.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "URINE COULD NOT BE DRAINED THROUGH THE BALLOON CATHETER. THE PATIENT IS IN GOOD HEALTH AND REQUIRES NO FURTHER MEDICAL INTERVENTION. THE PRODUCT USED HAS BEEN DISPOSED OF. URINE WAS NOT DRAINED, CAUSING THE BLADDER TO BECOME OVERFILLED AND OVERSTRETCHED." ADDITIONAL INFORMATION RECEIVED ON MAY 12, 2026, INDICATED THAT "A 6-FRENCH URINARY CATHETER INSERTED IMMEDIATELY BEFORE SURGERY FAILED TO DRAIN URINE. THIS LED TO MASSIVE DISTENSION AND OVERDISTENSION OF THE BLADDER. THE BLADDER WAS EMPTIED VIA THE CATHETER THROUGH MANUAL COMPRESSION. A SIMILAR INCIDENT OCCURRED IN TWO OTHER CHILDREN DURING THE SAME WEEK. THE CATHETERS WERE FROM THE SAME BATCH." FURTHER ADDITIONAL INFORMATION RECEIVED ON THE SAME DATE INDICATED THAT "THE CATHETER WAS CHANGED FOR ALL THREE CHILDREN. IN ONE CHILD'S CASE, THE PHYSICIAN WAS ABLE TO EMPTY THE BLADDER MECHANICALLY BY APPLYING PRESSURE TO THE ABDOMEN. THE CATHETER WAS THEN CHANGED AS WELL. NO ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ONLY AN ADDITIONAL CATHETER CHANGE." 3 PATIENTS. ASSOCIATED MDRS: 8040412-2026-00094 AND 8040412-2026-00095.