As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 05/2025).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.Device not returned.
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It was reported that during a chronic catheter placement procedure, the plastic piece that covers the tunneler allegedly disconnected from the tunneler and remained inside the patient.It was further reported that sometime post a catheter placement, the catheter was removed and the patient complained about the discomfort and the plastic piece was found inside the patient under ultrasound examination.Reportedly the plastic piece was removed.There was no reported patient injury.
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