Catalog Number 1003331 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The additional copilot devices referenced in are filed under separate medwatch reports.
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Event Description
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It was reported that when upackaging the copilots, it was noted that the copilot pouches had a black line across the label and the pouches were labeled "not for human use." the devices were not used, no patient involvement.There was no clinically significant delay during the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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