Catalog Number 324901 |
Device Problem
Missing Information (4053)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2023 |
Event Type
malfunction
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Event Description
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It was reported that prior to use with bd ultra-fine¿ insulin syringe it was discovered that there was missing label information.The following information was provided by the initial reporter: no ref = 1 cas.
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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H6: investigation summary no samples were returned therefore the investigation was performed based on the photo's provided.A total of nine photos with bd product information were provided.The customer reported that the shelf carton missing label information.The images were examined, and manufacturing (holdrege) was notified of the observed issue.On 23 feb 2023, manufacturing (holdrege) confirmed that the shipper case have only one label as per the packaging specifications.A dhr was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.Embecta was not able to duplicate or confirm the customer¿s indicated failure based on the photos received.
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Event Description
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It was reported that prior to use with bd ultra-fine¿ insulin syringe it was discovered that there was missing label information.The following information was provided by the initial reporter: no ref = 1 cas.
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Search Alerts/Recalls
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