Model Number 367986 |
Device Problem
Missing Information (4053)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2022 |
Event Type
malfunction
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Event Description
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It was reported when using the bd vacutainer® sst¿ blood collection tube there was no label or missing label information.The following information was provided by the initial reporter.The customer stated: "the tube had no label.".
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Manufacturer Narrative
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Investigation summary: bd had not received samples or photos for investigation.Therefore, thirty (30) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to missing 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 is unable to be confirmed for the indicated failure mode missing label.Bd was not able to identify a root cause for the indicated failure mode.
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Manufacturer Narrative
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The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 20-jan-2023.H.6.Investigation summary: bd received one (1) customer sample for investigation.The sample was evaluated by visual examination and the indicated failure mode for missing label was observed.Additionally, thirty (30) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to missing 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 mode.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported when using the bd vacutainer® sst¿ blood collection tube there was no label or missing label information the following information was provided by the initial reporter.The customer stated: "the tube had no label.".
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Search Alerts/Recalls
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