Catalog Number CA-11142-A |
Device Problems
Device Damaged Prior to Use (2284); Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device (with catalog# ca-11142-a) is not intended for sale in the us.Similar device/component sold in the us.
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Event Description
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The customer reports: conflicting information regarding product containing latex.Sticker label on packaging says latex free and package label says contains latex.The issue was noticed by the staff prior to insertion.
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Manufacturer Narrative
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(b)(4).The sample was not returned; however, the customer provided one photo of part of the product lidstock for lot#: 71f18j0795 for evaluation.Visual examination of the photo confirmed the lidstock said both "contains latex" and "latex free." a device history record review was performed and no relevant findings were identified.The customer reported issue of "latex" and "latex-free" on the lidstock was confirmed through visual examination of the customer-supplied photo.This misprint occurred during the packaging process; therefore, the probable root cause of this issue is packaging related.A non-conformance request has been initiated to further investigate this issue.
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Event Description
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The customer reports: conflicting information regarding product containing latex.Sticker label on packaging says latex free and package label says contains latex.The issue was noticed by the staff prior to insertion.
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Search Alerts/Recalls
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