As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation; however, case data has been provided.The investigation of the reported event is currently underway.Expiry date (04/2022).
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H10: manufacturing review: per the complaint history review, this is the first complaint reported for this lot number.Based upon the severity level and lot quantity, the number of complaints is below the aql threshold.A dhr review is not required investigation summary: a sample evaluation could not be performed as the samples were not returned.However, two electronic videos were reviewed.The first video was evaluated and reviewed.This is a movie of the injection of a gastrostomy tube.It is hard to tell how much is originating underneath the clear plastic stopper, but there appears to be a significant amount of fluid collecting on top of the plastic g tube stopper strap suggesting a ¿connection¿ problem with the injection tubing and not a leak from the g tube or from around the gastrostomy hole.The second video was reviewed.The video shows redness on the skin of the patient as well as the same leaking conditions that were observed in the first video minus the buildup of leaking fluid.The investigation is confirmed because of the leaking observed in the videos.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: b5, d4 expiry date (04/2022), g4.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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It was reported that some time post gastrostomy tube placement, the button valve allegedly leaked.It was further reported that the patient experienced burns in the gastro, major seizures, weight loss.The current patient status was unknown.
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