Model Number 367841 |
Device Problem
Device Contamination with Body Fluid (2317)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/03/2022 |
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 that bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes have blood pooling.The following information was provided by the initial reporter: "customer is reporting blood pooling on the cap of product 367841.".
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Event Description
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It was reported that bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes have blood pooling.The following information was provided by the initial reporter: "customer is reporting blood pooling on the cap of product 367841.".
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Manufacturer Narrative
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The following fields have been updated with additional information: d.9.Device available for eval? yes.D.9 returned to manufacturer on: 23-aug-2022.H.6.Investigation summary: bd received 1 sample and 1 photo for investigation.The photo was reviewed and the indicated failure mode for blood pooling was observed.Additionally, the customer sample along with 10 retention samples from bd inventory, were evaluated by functional testing and the issue of blood pooling was not observed.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.Bd was able to confirm the customer¿s indicated failure mode from the photos provided; however, the customer¿s failure mode could not be duplicated in the sample and retention testing.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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Search Alerts/Recalls
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