Catalog Number 368521 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2022 |
Event Type
malfunction
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Event Description
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It was reported when using the bd vacutainer® naf 6.0mg na2edta 12.0mg plus blood collection tubes were bent.The following information was provided by the initial reporter.The customer stated: verbatim: ¿crashed line 4 au2 , bent probe.".
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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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H.6.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for failed stopper function with the incident lot was not observed.Additionally, 24 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to failed stopper function 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 failed stopper function.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® naf 6.0mg na2edta 12.0mg plus blood collection tubes were bent.The following information was provided by the initial reporter.The customer stated: verbatim: ¿crashed.Line 4 au2.¿ bent probe.".
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Search Alerts/Recalls
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