Model Number 1012268-12U |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the 1.20x12mm mini trek pouch was creased and the device sterility was compromised.There was no damage to the chipboard box.There was no patient involvement.No additional information was provided.
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Manufacturer Narrative
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A visual inspection was performed on the returned packaged device and the reported creases and sterility issues were unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.The investigation determined the reported packaging creases and sterility issues appear to be related to operational circumstances of the procedure.It is likely that the noted indentations on the pouch caused the appearance of creases and they thought likely sterility issues.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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