(b)(4).The customer returned one opened kit and dilator for evaluation.Visual examination revealed the tip of the dilator is split and compressed.The device contains white coloration, indicating the dilator was under stress.The dilator contained signs of use in the form of biological material on the tip.The length and outer diameter of the returned dilator were measured and were found to be within specification.The inner diameter of the tip of the returned dilator could not be measured as the tip was damaged.A device history record (dhr) review was performed with no relevant findings.The instructions for use (ifu) provided with this kit instructs the user to "enlarge cutaneous puncture site with cutting edge of scalpel positioned away from the spring-wire guide" before dilating skin.The customer complaint of a damaged dilator tip was confirmed by complaint investigation.The returned dilator tip was compressed , split, and bent.The tip also contained white stress marks, indicating force caused the damage.A dhr review was performed with no relevant findings to suggest a manufacturing related issue.Based on the sample as received and the report that the event happened during use , it was determined that operational context caused or contributed to this event.
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