H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one feeding tube adapter was received for evaluation.Gross examination of the feeding tube adapter showed fins of the same material remaining on the cap.The investigation is confirmed for the alleged fitting issue as well as the leak that this fitting issue would cause if infused.An electronic photo was also reviewed confirming the findings from sample evaluation.The root cause has been determined to be manufacturing related.It is unknown whether patient and/or procedural factors contributed to the event.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.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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