The product is not available to be returned for evaluation.A review of the device history records and inspection records was conducted, and no similar concerns were found.Without the return of the sample, a root cause for the complaint occurrence could not be determined with confidence.Per the risk management documentation, potential causes include product shifting during shipping and handling and manipulation of the assembly in the user environment (i.E.Catheter withdrawn through needle).Without the return of the product, the product complaint could not be confirmed.
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