Catalog Number 367846 |
Device Problem
Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2022 |
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 the before using bd vacutainer® edta 2k the label was torn.The following information was provided by the initial reporter translated from japanese to english: the customer reported that the label was torn.
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Event Description
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It was reported the before using bd vacutainer® edta 2k the label was torn.The following information was provided by the initial reporter translated from japanese to english: the customer reported that the label was torn.
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Manufacturer Narrative
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H.6.Investigation summary: no samples and no photos were returned by the customer in support of this complaint.The 100 retentions were visually inspected with no issues being identified.Bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were returned.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.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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Search Alerts/Recalls
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