Samples were received to perform an investigation.Six samples were received for this complaint in unused conditions without their original package inside plastic bags.A visual inspection of the samples found no relationship to the complaint.Functional testing was done.The retractor was activated to perform the insertion to a white sponge used as the reference of the skin.The retractor activated with no problems, adhesive shows good adhesion to the sponge, the dispositive could be separated from the adhesive without problem in all samples.A device history record (dhr) review found no discrepancies or anomalies relevant to the complaint.No root cause could be determined as the complaint could not be confirmed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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