Catalog Number 367861 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2022 |
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® k2 edta (k2e) 7.2mg blood collection tubes, the device experienced sterility problems.The following information was provided by the initial reporter.The customer stated: it was reported that tubes are damaged inside of damaged box.Customer began to break down a shipment of tubes and noticed damaged product in the middle of the shipment.Pictures attached.
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Manufacturer Narrative
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H.6.Investigation: bd received 2 photos from the customer in support of this complaint.A visual examination of the photos was performed and revealed damage to the case of product.The product does not leave the manufacturing site in this condition.Bd was able to confirm the customer¿s indicated failure mode with the photos provided.The exact cause of 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® k2 edta (k2e) 7.2mg blood collection tubes, the device experienced sterility problems.The following information was provided by the initial reporter.The customer stated: it was reported that tubes are damaged inside of damaged box.Customer began to break down a shipment of tubes and noticed damaged product in the middle of the shipment.
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Search Alerts/Recalls
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