Model Number 368861 |
Device Problem
Missing Information (4053)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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® k2e 7.2mg plus blood collection tube there was no label or missing label information.The following information was provided by the initial reporter.The customer stated: "there are tubes where the label is not stuck properly.Some tubes have no label, often the tube next to them has 2.The adhesive edges are sometimes loose which can cause interference on the pre-analytical module.".
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Event Description
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It was reported when using the bd vacutainer® k2e 7.2mg plus blood collection tube there was no label or missing label information.The following information was provided by the initial reporter.The customer stated: "there are tubes where the label is not stuck properly.Some tubes have no label, often the tube next to them has 2.The adhesive edges are sometimes loose which can cause interference on the pre-analytical module.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-01-03.H.6.Investigation summary: bd received one photograph and 6 samples from the customer in support of this complaint.An evaluation of the samples and photo attached shows evidence of lifted labels and missing labels on the tubes.Additionally, 100 retained samples from the bd inventory were visually checked and no defects were found.Bd was able to duplicate or confirm the customer¿s indicated failure from the photograph and samples provided, however, retained samples were satisfactory.Bd was not able to identify a root cause for the indicated failure mode.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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