Catalog Number 364902 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2021 |
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® luer-lok¿ access device holder with pre-attached multiple sample adapter, the device experienced unable to fill tube completely.The following information was provided by the initial reporter.The customer stated: unable to draw blood.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-29.H6: investigation summary: bd received 1 used sample and 1 photo for investigation.The sample and photo were reviewed and the indicated failure mode for unable to draw blood with the incident lot was not observed.The sample had blood on the inner diameter of the luer hub but did not show any signs of leakage or damaged components.Additionally, 12 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to unable to draw 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 unable to draw blood.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® luer-lok¿ access device holder with pre-attached multiple sample adapter, the device experienced unable to fill tube completely.The following information was provided by the initial reporter.The customer stated: unable to draw blood.
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Search Alerts/Recalls
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