A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.A visual inspection found that a small piece of plastic was detached from the connector body.The root cause of the reported issue could not be determined.Device information is unknown.No information has been provided to date this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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