Catalog Number 367525 |
Device Problems
Break (1069); Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2023 |
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® k2e (edta) 18.0mg plus blood collection tubes the tubes were cracked/damaged.The cracked event affected 1500 tubes.The damaged tube event affected 1500 tubes.The following information was provided by the initial reporter.The customer stated: "cat# 367525 many of these tubes have failed and have burst over time, post blood collection, they have found a lot of them break and burst out! this has caused us to lose many samples.".
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Manufacturer Narrative
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Bd did receive one photograph from the customer in support of this complaint.An evaluation of the photograph attached shows tubes filled with blood which had leaked on the eps tray.Additionally, 10 retained samples were visually inspected and no defects were found.The same 10 retained samples were functionally tested and one of the 10 retained samples burst or leaked.Bd was able to confirm the customer¿s indicated failure mode based on the photograph 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 h3 other text : see h.10.
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Event Description
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It was reported when using the bd vacutainer® k2e (edta) 18.0mg plus blood collection tubes the tubes were cracked/damaged.The cracked event affected 1500 tubes.The damaged tube event affected 1500 tubes.The following information was provided by the initial reporter.The customer stated: "cat# 367525 many of these tubes have failed and have burst over time, post blood collection, they have found a lot of them break and burst out! this has caused us to lose many samples.".
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Search Alerts/Recalls
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