It was reported to boston scientific corporation that a interject clear needle was used during a gastroscopy procedure performed on (b)(6) 2019.According to the complainant, during the preparation, they noticed that the needle was completely out of the sheet and therefore the sterile barrier of the packaging was compromised.It was also noted that the needle was prematurely extended, and the handle of the device was broken, upon removing from the package.The procedure was completed with another interject needle.There were no patient complications reported as a result of this event.
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