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 09/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer reports an inconsistent latex free labelling on the lid of the stock.The lid shows both "latex free" and "contains latex" labelling.The issue was detected during incoming inspection/inventory review.
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Event Description
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The customer reports an inconsistent latex free labelling on the lid of the stock.The lid shows both "latex free" and "contains latex" labelling.The issue was detected during incoming inspection/inventory review.
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Manufacturer Narrative
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(b)(4).The customer returned a closed mac finished kit for evaluation.Visual inspection of the closed kit revealed that the lidstock on the kit stated that the contents inside "contains latex" but also a figure that states the kit does not contain latex.The timestamp on the label was 1505264.A device history record review was performed and no relevant findings were identified.The customer reported issue of "latex" and "latex-free" on the lid stock was confirmed.Visual examination of the kit revealed that the label of the kit had contradicting information about latex inside the kit.A dhr review was completed with no relevant findings.The root cause of the complaint is likely packaging related.A non-conformance is currently in process to further investigate this issue.
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Search Alerts/Recalls
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