(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 discarded and not returned; therefore, a return sample evaluation is unable to be performed.A buried bumper (syndrome) 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 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.In (b)(6) 2019, a physician reported to a nurse that a patient experienced a buried bumper and the tubing was removed.It was reported that the patient received a direct jejuno cath during the surgery to continue duodopa therapy.
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