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Description of event: this file is related to patient reference 316441.When the device was returned for patient reference (b)(4), four additional sealed devices were also returned that had cracks in them.Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), drawings,manufacturing instructions, and quality control data.The complainant returned additional unopened devices for another complaint (reference patient identifier (b)(6)).Four of the unopened devices had cracks and leaked during tabletop testing.This complaint was opened on those four devices.Analysis of the failed devices showed: four unopened devices were found to have visible cracks.The stopcocks were leak tested and found leaks were present.At this time, cook concluded that the devices were manufactured within specification.In response to this incident, cook completed a review of the dhr.The dhr for the reported lot records no relevant non-conformances.A database search for complaints on the reported lot found 3 additional complaints reported from the field.Although multiple complaints have been reported for this lot, a capa investigation was previously completed and found that the root cause of cracking/leaking stopcocks is due to the products absorbing moisture.The device's design history files (dhf) were reviewed, and the risks associated with these devices are acceptable when weighed against the benefits.Due to this environmental effect, cook could not conclude that nonconforming product from this lot exists in house or in the field.The reported product does not come provided with an instructions for use (ifu) pamphlet.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded the device design contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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