This complaint was originally reported to amt on 01/11/2024 by (b)(6) of (b)(6) medical center.The device was then returned for inspection and analyized.On (b)(6) 2024, amt was notified of a medwatch report regarding this device.There was no information provided that a death, serious injury, or any other harm occurred with the patient.A response is being sent to fda as the incident was reported under medwatch report #(b)(4).The information provided by the patient is that the tube clogged and when they went to use the tube, a hole formed in the sillicone stoma portion of the device.The examination of the device found that the jejunal tube section had shifted down in the external body, with signs of residue and clogging noted within 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 pushed the internal tube down, tearing part 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.We have assigned the internal complaint # (b)(4) to this record.
|