Catalog Number 381844 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Event Description
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It was reported that bd insyte autoguard package stickers are missing.The following information was provided by the initial reporter, translated from spanish to english: during the inspection, imported medical devices were found that did not have packaging stickers on their packaging.Service for the pertinent management with the supplier.
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Manufacturer Narrative
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A lot number was received and has been included.Correction cancel mdr: an email stating that the invima sticker is not provided by bd has been received.It is a sanitary registration# sticker is from invima, and this is not placed by the bd plant, this is a local process.As no product quality issue is reported, this does not qualify as a bd product complaint.The complaint will be closed / cancelled.
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Search Alerts/Recalls
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