(b)(4).The customer returned one catheter for investigation.Visual examination of the returned catheter revealed that both wings of the suture site on the juncture hub were severed.Microscopic examination of the point of separation revealed that the material is uneven and jagged.No pieces appear to be missing.No additional defects or anomalies were observed.The lot number was not reported by the customer; therefore, sales history records were reviewed for the most recent lot sold to the customer prior to the event.A device history record (dhr) review was performed on that lot number and there were no relevant findings.The instructions-for-use (ifu) that are packaged with this product suggest using the catheter clamp and fastener as secondary securement sites to mitigate the risk of catheter migration.The reported complaint of the migration of the catheter was confirmed through visual examination of the returned sample.Both suture wings were found to be torn.Visual examination of the point of separation revealed that the material appeared jagged and uneven as if the material was torn.A dhr review was performed based on sales history with no evidence to suggest a manufacturing related cause.Based upon the complaint report, which states, "the little wings in plastic were sheared by the suture thread," the torn suture wings caused the catheter to migrate.Based on that description and the type of damage observed, it was determined that operational context caused or contributed to this event.
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