Catalog Number 367840 |
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 02/02/2022 |
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® k2 edta (k2e) plus blood collection tube the stopper was damaged.The following information was provided by the initial reporter.The customer stated: "the rubber stopper was cracked.".
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Manufacturer Narrative
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H.6.Investigation: bd had not received samples or photos for investigation.Therefore, 100 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to damaged stopper 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 damaged stopper.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® k2 edta (k2e) plus blood collection tube the stopper was damaged.The following information was provided by the initial reporter.The customer stated: "the rubber stopper was cracked.".
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Search Alerts/Recalls
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