Reference record (b)(4).The device manufacturer and lot number of the device involved in this complaint was not provided.Therefore, it is unknown if the device involved was abbvie branded tubing.Conservatively, abbvie has chosen to report this complaint due to the potential that the device involved could have been abbvie branded tubing.The device involved in the event was not returned and was discarded; therefore, a return sample evaluation is unable to be performed.A buried bumper is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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On an unknown date, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2019, it was discovered that the peg tube was difficult to flush, and dipping of the tube was no longer possible.On (b)(6) 2019, during endoscopy to replace the peg-j tubing, a buried bumper was discovered.The buried bumper was cut away, and a new peg-j tube was placed in the same stoma site.
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