Asp investigation summary: the investigation included a review of the device history record (dhr), service history, trending of the product malfunction code, and system hazard and user misuse analysis (shuma).Method - service history, trending and shuma reviewed.The dhr was not reviewed as the lot number of the cassette was not available.The service history trending was not performed as lot number of the involved cassette is not available.The trend for the product malfunction code of skin reaction was assessed from october 2013 through september 2014.The risk is considered "low." the shuma indicates the risk is "broadly acceptable." the instructions for use (ifu) of the sterrad® 100nx cassette state: "caution: wear personal protective equipment if handling a used cassette, or any of the cassette case components that may have been subject to liquid leak.This includes a cassette that has been ejected (for any reason) after insertion." testing was not performed as no product was required to be returned.The assignable cause of the reported issue is user error as no ppe was used when handling a used cassette.The customer reported they knew to wear ppe when handling a used cassette.No customer letter will be sent.The issue will be tracked and trended.No further investigation is necessary at this time.
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