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 were performed.It was confirmed the needle inside the cover was bent the product sample was received for evaluation and was forwarded to the supplier for analysis.Functional testing and root cause analysis are in progress.Should additional information be returned pertinent to the investigation, a supplemental report will be filed.Report source is unknown.No information has been provided to expiration date is unknown.No product 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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