H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2025).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 : device pending return.
|
It was reported that two weeks post catheter insertion, the catheter allegedly leaked at the extension part.It was further reported that the physician was scheduled to remove and replace the catheter set.The patient received hemodialysis treatment three times a week for underlining diseases.Reportedly, the patient expired the next day before the scheduled procedure due to sepsis from an alleged wound in the right toe.It is unknown if the device caused or contributed to the reported sepsis.
|