Model Number 4700 |
Device Problems
Break (1069); Incomplete or Missing Packaging (2312)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: as received, the tamper seal of the shelf box was broken and the patch jar was missing the shrink wrap seal.No damage was found to patch jar and jar still contained patch and glutaraldehyde solution.Tagalert was not returned.Any packaging non-conformance that results in a breach of the sterile package (i.E.Pinhole, tear or seal issue), has the potential to result in a serious infection.Per the product evaluation, the customer report of that "plastic cover around the top of a pericardial patch was broken" was confirmed.An engineering task has been opened and assigned for further investigation.A supplemental report will be submitted upon completion.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Event Description
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Edwards received information that the plastic cover around the top of a pericardial patch jar was broken prior to use.
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Manufacturer Narrative
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Additional manufacturer narrative: per the product evaluation, the customer report of that "plastic cover around the top of a pericardial patch was broken" was confirmed.Per the engineering evaluation, the root cause of the alleged broken shrink seal is unable to be determined based on the evidence of the returned device, but it¿s highly unlikely the device left edwards in this manner.A manufacturing defect was not confirmed.Ifu has been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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Search Alerts/Recalls
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