Catalog Number 367846 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2022 |
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 customer found a plastic piece floating inside the tube.The following information was provided by the initial reporter.The customer stated: "the customer's verbatim report is that a plastic piece is floating inside the tube.".
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Manufacturer Narrative
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The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 20-dec-2022.Bd received 1 sample and 4 photos from the customer in support of this complaint.A visual examination of sample and photos was performed and revealed foreign matter on the inside of the tube.There is a piece of plastic found on the inside 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 reported issue 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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.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 when using the bd vacutainer® edta 2k customer found a plastic piece floating inside the tube.The following information was provided by the initial reporter.The customer stated: "the customer's verbatim report is that a plastic piece is floating inside the tube.
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Search Alerts/Recalls
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