Catalog Number NSE4100CJP |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A sample was received to perform an investigation.A visual inspection confirmed the reported problem.The hinge was found broken and the connector was damaged.The kit manufacturing process had a 100% inspection performed on the appearance of connectors before setting.The root cause is likely due to the molding design of the product.A device history record (dhr) review was performed and found no discrepancies or anomalies.No product information has been provided to date.(b)(4).
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Event Description
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It was reported that upon use of the product, the customer noticed the connector was damaged.No patient injury was reported.
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Search Alerts/Recalls
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