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.Expiration date: 07/2023.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.Device pending return.
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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 with a loaded right angle non-coring needle were returned for evaluation.Functional, gross visual, and microscopic visual evaluations were performed.The investigation is confirmed for the reported obstruction of flow and difficult to flush issues and the identified needle bent and fluid leak issues, as the needle was noted to be bent.Furthermore, an attempt to infuse the right angle non-coring needle after getting removed from the port with an in-house syringe was performed and was unsuccessful.Water was observed leaking from the needle hub.An attempt to infuse the received implantable port with the loaded needle with an in-house syringe was performed and was unsuccessful.Water was not observed exiting the port stem and exiting the needle hub.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 (expiration date: 07/2023), 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.
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