Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062910.At the time of report, it is unknown if the device involved in the event will be returned; therefore, a return sample evaluation is unable to be performed.However, if the device is received, a follow up report will be submitted upon completion of the return sample investigation.A buried bumper is a known complication of a peg 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) 2018, a patient in belgium underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2021 during a tubing replacement, it was reported that the jejunal tube (j-tube) could not be removed due to a buried bumper.The buried bumper was scheduled to be removed.
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