(b)(4).Udi # unknown.The complaint product was not returned for evaluation.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.
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Halyard received a single report that referenced three different incidents, which were associated with separate devices, involving the same patient.This is the third of three reports.Refer to 2026095-2016-00170 for the first report.Refer to 2026095-2016-00177 for the third report.Fill volume: 400 ml, flow rate: unknown, procedure: unknown, cathplace: n/a.It was reported that a patient experienced three issues in three days with three different devices that infused solumedrol.The first day, the patient was being infused with 400 ml, which completed within two hours.On the second day, the patient was infused within three hours and 15 minutes.On the third day, the patient was infused with 500 ml within four hours.The environment and conditions were similar.The devices were discarded.The patient experienced tachycardia, a metallic taste in the mouth, and anguish.
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