Model Number 181859CS-V-A2 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A search for non-conformance associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device has not yet been returned to the manufacturer for analysis.(b)(4).
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Event Description
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It was reported that the product information on the outer box label did not match the product information on the inner pouch label.The device was not used in the patient.
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Manufacturer Narrative
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Investigation of the returned packaging and device revealed that rework was performed at the fedex warehouse in netherlands to replace damaged outer carton boxes.Replacement boxes and box labels for two devices were sent as part of the rework order.It was determined that the boxes and pouches were inadvertently interchanged during the rework process at fedex.
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Search Alerts/Recalls
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