H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one tri-funnel replacement gastrostomy tube 24f was returned for evaluation.The gross visual observed are the sample appeared to be clean.Unknown fibers were noted to the distal end of the gastrostomy tube.The microscopic visual observed the unknown fibers were noted on the outside of the balloon.Functional testing, tactile evaluation and other evaluation/testing was not performed due to the nature of this complaint.The investigation is confirmed for contamination problem, as unknown fibers were found outside of the balloon.A definitive root cause could not be determined based upon available information.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.H10: d4(expiry date: 06/2023),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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