Model Number 367960 |
Device Problem
Component Misassembled (4004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2022 |
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® pst¿ gel and lithium heparin(lh) blood collection tubes the cover is loose.The following information was provided by the initial reporter.The customer stated: ¿after opening the cover, put it back on, the cover will come loose.¿.
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Event Description
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It was reported when using the bd vacutainer® pst¿ gel and lithium heparin(lh) blood collection tubes the cover is loose.The following information was provided by the initial reporter.The customer stated: ¿after opening the cover, put it back on, the cover will come loose¿.
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Manufacturer Narrative
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H.6.Investigation summary: mat: 367960, lot: 2042052.No sample and no photos were returned by the customer in support of this complaint.Therefore, (b)(4) retentions were visually inspected with the hemogard closure assembly correctly assembled and placed on the tubes.There were no cocked stoppers identified that would cause the hemogard closure assembly to not be applied correctly.(b)(4) retention samples were draw tested with all weights being within specification limits.No issues with the hemogard closure assembly being loose or separating during or after the draw testing was completed.Bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were received, and the retention samples did not exhibit the customer¿s failure mode of ¿stopper pop off¿.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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Search Alerts/Recalls
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