Catalog Number 364305 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.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® blood collection tube buffered sodium citrate the cap was defected.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: defect: found cap defect.Quantity: 2.Effects: no effect on patients and users.
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Manufacturer Narrative
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H.6 investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for molding defect was observed.Additionally, (b)(4) retention samples from bd inventory were evaluated by visual examination and the issue of molding defect 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.This complaint has been confirmed for the indicated failure mode molding defect.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® blood collection tube buffered sodium citrate the cap was defected.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: defect: found cap defect quantity: (b)(4).Effects: no effect on patients and users.
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Search Alerts/Recalls
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