Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address = phone: (b)(6), postal code: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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As reported, prior to use for an unknown procedure, a thin strand of plastic came off the side of a cxi support catheter.The catheter was removed from the package, which was not damaged, and was then flushed as normal, without difficulty.Prior to advancement of the catheter over an unspecified wire guide, the catheter was inspected, and a thin strand of plastic was noted to come from the side of the catheter, "about one-third of the total length back from the tip".The catheter was never advanced over the wire.The catheter was not used and never entered the patient.Another catheter was used to complete the procedure.There was no harm to the patient.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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