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 complaint history for this finished good lot (71f18j0795) was reviewed and similar previously confirmed complaints were identified.A non-conformance was initiated based on a confirmed packaging issue that matches the issue described in this complaint report.The packaging issue likely affected the entire finished good lot; therefore, the customer report can be confirmed.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 through a complaint history review for this lot.This misprint occurred during the packaging process; therefore, the probable root cause of this issue is 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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