Catalog Number 367955 |
Device Problems
Illegible Information (4050); Missing Information (4053)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/06/2022 |
Event Type
malfunction
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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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Event Description
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It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes device experienced missing label information.This event occurred five times.The following information was provided by the initial reporter.The customer stated: customers open the packaging units, some tubes have no paper label at all, some tubes have two paper labels.
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Manufacturer Narrative
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Supplemental: the following fields have been updated: d.9 device available for eval? yes returned to manufacturer on - 08/17/2022 h.6 investigation summary bd received three (3) samples for investigation.The samples were evaluated by visual examination and the indicated failure modes for missing label and excess label with the incident lot was observed.Two tubes had no label and one tube had two labels.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to missing label or excess label as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure modes of missing label and excess label.Bd was not able to identify a root cause for the indicated failure mode.
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Event Description
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It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes device experienced missing label information.This event occurred five times.The following information was provided by the initial reporter.The customer stated: customers open the packaging units, some tubes have no paper label at all, some tubes have two paper labels.
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Search Alerts/Recalls
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