Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062910.The device involved in the event was not returned and the device disposition is unknown; therefore, a return sample evaluation is unable to be performed. a bowel perforation and post procedural infection 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.During the procedure, it was reported that the j-tube and grasper perforated through the wall of the duodenum.The j-tube was placed just beyond the perforation.The patient completed a ct scan with oral contrast, to be reviewed by surgical registrar to confirm placement.The patient was treated with intravenous antibiotics, metronidazole twice daily and ceftriaxone daily.
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