Catalog Number 367846 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2022 |
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® edta 2k, the device experienced a cracked tube.This event occurred once.The following information was provided by the initial reporter.The customer stated: the customer reported about a damage/scratch on the tube.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 07-dec-2022.H6.Investigation summary: bd received 1 sample and 5 photos from the customer in support of this complaint.A visual examination of the sample and photos was performed and revealed damage to the outside of the tube.Bd was able to confirm the customer¿s indicated failure mode with the sample and photos provided.The exact cause for the customer¿s failure mode 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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Event Description
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It was reported when using the bd vacutainer® edta 2k, the device experienced a cracked tube.This event occurred once.The following information was provided by the initial reporter.The customer stated: the customer reported about a damage/scratch on the tube.
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Search Alerts/Recalls
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