H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ponsky dual port feeding tube adapter was returned for evaluation.Gross visual evaluation was performed.The medication port was noted to be open and the caps on the device appeared intact.Based on the sample evaluation, the investigation is unconfirmed for the loose cap issue as the cap on the large port was able to be closed and opened without issue; the cap did not appear loose.Based upon the available information, the definitive root cause for this event is unknown.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: 12/2099), h11: h6 (result, conclusion).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.H3 other text : see h10.
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