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 sealed bard mri implantable port kit was returned for evaluation.Gross visual evaluation was performed.Although the sample was returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported defective component and the identified deformation and fracture issues, as the guidewire was noted to be bent and deformed on its distal tip.One side of the t-handle of the 10fr peel-apart sheath was noted to be fractured.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.(expiry date: 01/2026).
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