Catalog Number 362780 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2023 |
Event Type
malfunction
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Event Description
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It was reported that while using bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml, 5 tubes broke after centrifugation.No patient impact reported.The following information was provided by the initial reporter: "breakage of tubes after centrifugation - 5 tubes for the moment.I asked regarding the centrifugation condition - they used swing-out centrifuge and centrifuged at 1800 rcf for 30 minutes.This is the first time when is happening, they are using this tubes for long time.I would like to mention that the customer ordered also 4ml cpt tubes and using the same protocol and breakage never happened.Will have tubes for evaluation from this batch.".
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Manufacturer Narrative
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H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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Bd had not received samples or photos for investigation.Therefore, 60 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to glass breakage 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 glass breakage.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.H3 other text : see h.10.
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Event Description
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It was reported that while using bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml, 5 tubes broke after centrifugation.No patient impact reported.The following information was provided by the initial reporter: "breakage of tubes after centrifugation - 5 tubes for the moment.I asked regarding the centrifugation condition - they used swing-out centrifuge and centrifuged at 1800 rcf for 30 minutes.This is the first time when is happening, they are using this tubes for long time.I would like to mention that the customer ordered also 4ml cpt tubes and using the same protocol and breakage never happened.Will have tubes for evaluation from this batch.".
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Search Alerts/Recalls
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