This complaint was originally reported to amt on 12/28/2023.There was no information provided that a death, serious injury, or any other harm occurred with the patient.A report is being sent to fda as a portion of the device was thrown up by the patient.The information provided by the patient is that they were putting water through the tube to clear a clog, felt the tube unclog, but the patient threw up the blue tube portion later that night.The examination of the device found that the jejunal tube section had separated from the external body, with signs of residue and clogging noted with the external bolster and tubing areas.It was concluded that in attempts to clear a tough clog through the tube, the user increased pressure inside of the tube high enough that it separated the internal tube from the rest of the device.Based on the provided information and examination of the device, there was no evidence found that would indicate the failure was due to a manufacturing defect or quality issue.The device was in use for roughly one month before the failure occurred, indicating that the device was properly functioning during this time.We have assigned complaint # (b)(4) to this record.
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