H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport slim implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510k number for the powerport slim implantable port, chronoflex single-lumen, kit, 6f products is identified in d2 and g4.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 slim implantable port was returned for evaluation.Gross visual and microscopic visual evaluations were performed.One suture plug was received detached from the port body.Therefore, the investigation is confirmed for the reported suture plug detachment and lack of adhesive issue.A definitive root cause could not be determined for the reported event.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 01/2025) h11: section a through f ¿ the information provided by bd represents all 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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