This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: tip break.Probable root cause: design: inadequate material selection to support movement/manipulation by user.Inadequate molding/assembly design, poor strength of design.Manufacturing: cannula not assembled, molded or machined to specification application.Excessive force; the reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.H3 other text : 81.
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