Catalog Number 362780 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2022 |
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® cpt¿ nh: ~130 iu ficoll¿: 2.0ml and it was broken.The following information was provided by the initial reporter.The customer stated: ¿site used the tube (collected sample), sent sample back to distributor to process the sample, and it was broken.Upon receipt¿.
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Event Description
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It was reported when using the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml and it was broken.The following information was provided by the initial reporter.The customer stated: ¿site used the tube (collected sample), sent sample back to distributor to process the sample, and it was broken.Upon receipt¿.
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Manufacturer Narrative
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Investigation summary: bd received 2 photos from the customer in support of this complaint.A visual examination of photos was performed and revealed broken tubes.Additionally, 60 retention samples were inspected with no issues being identified.Bd was able to confirm the customer¿s indicated failure mode with the photos provided.The exact cause for the glass breakage could not be determined.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.
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Search Alerts/Recalls
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