The complaint of a defective device was confirmed and the cause was packaging related.One 22g nexiva unit from lot #3116955 was provided for investigation.The nexiva catheter was caught between the sealing surfaces of the top and bottom web packaging, which created gaps in the seal.The appropriate manufacturing personnel were notified of this complaint.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Reporter facility full name: (b)(6) medical center elk.
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