A device was placed in a (b)(6) year old male patient.The catheter became clogged three weeks later.On (b)(6) 2015, the device was removed and replaced with another catheter.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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A review of complaint history, instructions for use (ifu), quality control, and a visual inspection of the returned device was conducted during the investigation.The product was returned in an opened and used condition.A visual inspection noted that the lumen and 29.2cm segment of shaft were observed to be intact.Silicone seal is unbroken between the hub and the snt.Rings and felt were secure and in place.Dark spots within the lumen along the shaft indicate multiple bio occlusions.Attempts to flush the device failed as the catheter was occluded.There is no evidence to suggest that the product was not manufactured to specifications.This product is shipped with an instructions for use, which states warnings, precautions and instructions for use.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
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