Reference number (b)(4).Catalog number in is the international list number which is similar to us list number of 062918.The device involved in the event was not returned; therefore, a return sample evaluation is unable to be performed.Bezoar is a known complication of a peg- j tube placement.(b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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On (b)(6) 2021, a patient in spain underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2022, an exploratory gastroscopy was performed.It was observed that the internal stopper of the peg passed the pylorus and was in the part of a jejunum, and that at the distal end of the pei tube, a large phytobezoar had formed.The entire system was removed and a new peg/pei placed, and the incident was resolved.
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