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 powerport mri implantable port kit was returned for evaluation.Functional, gross visual, and microscopic visual evaluations were performed.The investigation is confirmed for the reported fracture and the identified stretched issues, as uncoiling was noted throughout a portion of the guidewire, proximal to the introducer needle hub.A complete break was noted on the flat core wire.However the investigation is inconclusive for the reported failure to advance issue, as the exact circumstances at the time of the reported event cannot be verified, and the reported event could not be reproduced in the lab.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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: d4 (expiry date: 04/2024), g3, h6 (device).H11: h6 (method, 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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