This mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The device was received for evaluation.Visual and functional testing were performed.Visual inspection revealed that the catheters and connectors were not assembled.The connectors were in the fully engaged position (closed) upon receipt.Dimensional evaluation was conducted on the returned samples.All dimensions were found to be within specification.However, both assemblies failed to remain assembled when tested with 5n weight.While consideration may be made to account for the condition of the used samples prior to testing, the separation of the components confirmed the complaint.However, the root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.(udi) and are unknown.No product information has been provided to date.
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