The device history record (dhr) could not be reviewed because there was no serial number provided by the customer.The device was already used on patient therefore it could not be taken to production line for evaluation following customs policy; the product evaluation is not able to be performed.The photo of the device confirms that the tube was cut off by something; a cutting edge could be observed.The investigation found that there were no related issues recorded throughout the manufacturing and control processes.The manufacturing records, including assembly, test, inspection and packaging, no risk cause y port detach.All tubes have been 100% tested by leak test station follow customer specification of air pressure 20psi.Any of leakage issue could be detected if y port detached.All tubes have been 100% inspected before packaging.Based on the investigation, the broken tube was cut off by something at the customer site.This issue was not a production related issue.The root cause could not be determined due to limited information.No corrective actions are required at this time.
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