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 07/18/2023 |
Event Type
malfunction
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Event Description
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It was reported that while using bd vacutainer® blood collection tubes buffered sodium citrate 0.3ml - 0.109m that there was a broken lid/ cap.The following information was provided by the initial reporter: when affixing the inspection barcode, it was found that the cap of the blood collection tube was missing a piece.It should be a product quality problem.Replace immediately and report.No harm was done to the patient.
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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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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 of molding defect was observed.Additionally, 100 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.
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Event Description
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It was reported that while using bd vacutainer® blood collection tubes buffered sodium citrate 0.3ml - 0.109m that there was a broken lid/ cap.The following information was provided by the initial reporter: when affixing the inspection barcode, it was found that the cap of the blood collection tube was missing a piece.It should be a product quality problem.Replace immediately and report.No harm was done to the patient.
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Search Alerts/Recalls
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