It was reported that a portex® combined spinal epidural system catheter did not have a hole at the tip and fluid was unable to be delivered.The issue was observed during a spinal attempt during a cesarean section procedure.The device was placed by anesthesia staff.It was observed after the epidural catheter was removed that it was not perforated at the patient end, 1cm from the catheter tip, as expected.General anesthesia was administered to address the epidural issue.The cesarean section was reported to be successful.No injury was reported.See mfr: 3012307300-2017-00634.
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One used 6ml hypodermic syringe was returned for investigation.The sample was received with a non-smiths medical device assembled to the syringe by a luer connection.The opposite end of the non-smiths medical device was assembled to a portion of the epidural catheter which was approximately 3.5" in length; this portion had been taken from the patient end.Approximately 2.5" of the catheter fragmented protruded from the non-smiths medical device.The catheter fragment was microscopically inspected and it was found that the three eyes, which are typically located at the tip of the patient end, were not present.During functional testing, attempts were made to push fluid through the assembly; however, the fluid was unable to move through.Additionally, attempts to push fluid were made using the smiths epidural connection; the fluid was unable to pass through.Investigation confirmed the reported complaint and determined that the root cause of the event was due to the catheter component which is a supplied item.
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