As reported, the customer reported finding 4f tempo 65 cm angiographic catheters still in sterile package: however, damaged, and unusable.They claim to have received the product in this fashion.A picture showing three (3) sterile tempo catheters was provided for review and pieces of the coating on the catheters appear to be flaking off the devices.The products were never opened or used in the patient.There was no reported patient injury.The exact event date is unknown.This complaint involves two (2) tempo catheters of lot number 18168805.The condition was noticed prior to use.There was no damage to the shipping box, no damage to the outer product box or the inner product pouch.The sterile pouch was not received open/compromised.The products are stored in the lab hanging in racks.The devices are expected to be returned for evaluation.
|