A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.One 24g via valve device, without blister packaging, was returned for analysis.The sample was visually examined under magnification for any potentially related non-conformances.The needle guard assembly displayed no evidence of any cannula od to nose id gaping that could potentially result in the reported leakage.Additionally, there was no evidence of blood pooling inside the guard component id.Initial visual examination of the catheter assembly did not reveal any unusual conditions that would cause the complaint.Pressure testing, using a water filled syringe, of the catheter assembly indicated no evidence of leakage in the catheter assembly.The seal component was gently removed from the catheter assembly for examination with no visible damage noted in the component id.Based on sample review, the complaint cannot be confirmed as a manufacturing nonconformance.No correction or corrective actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.Operator of device unknown this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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