H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium implantable port, hickman single-lumen, 9.6f that are cleared in the us.The pro code and 510 k number for the titanium implantable port, hickman single-lumen, 9.6f are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2025).H11: section a through f ¿ the information provide 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 : device pending return.
|