H10: manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: one tri-funnel replacement gastrostomy tube 20f was returned for evaluation.Gross visual, microscopic visual and functional evaluations were performed.Therefore, the investigation is confirmed for fluid leak, split, balloon shrank and dislodgement issue as the balloon was inflated with approximately 10ml of water and a leak was immediately noted on the tube, just distal to the inflation hub.The area of the leak was examined under a microscope and a split was found.The edges of the split appeared cleanly cut.Based upon the available information, the definitive root cause could not be determined.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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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