Catalog Number 362780 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 breakage occurred during use with a bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0 ml.The following information was provided by the initial reporter, "customer states that cpt tubes broke in centrifuge on multiple occasions." 6 occurrences were reported, but the dates and times were not provided.
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd 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 that breakage occurred during use with a bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml.The following information was provided by the initial reporter, "customer states that cpt tubes broke in centrifuge on multiple occasions." 6 occurrences were reported, but the dates and times were not provided.
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Search Alerts/Recalls
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