H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one tri-funnel replacement gastrostomy tube were received for evaluation.Gross visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the identified fracture issue as a compound break was noted approximately 1.1cm from the end part of the device and the break appeared to be jagged.However, the investigation is inconclusive for the reported catheter dislodgement and migration, as the exact circumstances during the reported event were unknown.A definitive root cause could not be determined based upon the 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: g3, h6 (device, method) h11: b5, h1, h6 (patient, 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.See h10.
|