Information was received indicating that the patient's arm was reported to catch on a smiths medical cleo® 90 infusion set, pulling out the connector and cannula.It was reported that the patient was unable to operate the connector and had difficulty disconnecting the site connector from the cannula pad.The patient experienced cellulitis at the infusion site; right lower quadrant of abdomen.Subsequently, a reported therapy was required to be initiated to resolve the cellulitis.No further adverse effects were reported.
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Other text: this mdr was generated under protocol b10009704, as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No corrective actions are required since the complaint could not be confirmed since no samples or pictures were received for evaluation.
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