Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062918.The device involved in the event was discarded; therefore, a return sample evaluation is unable to be performed.(b)(4).A bezoar and gastrointestinal ulcer are known complications of a j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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On (b)(6) 2020, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.In (b)(6) 2021, the patient experienced black stool, and a subsequent lab test showed anemia.The patient was admitted to the hospital until an endoscopy could be performed.On an unknown date in (b)(6) 2021, the patient underwent an endoscopy which showed the j-tube was knotted, the internal plate had migrated past the pylorus, and a bezoar was observed.There was decubitus ulceration, which was not bleeding, in the path of the j-tube.The j-tube was replaced during the endoscopy.The date of discharge from the hospital was not reported.
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