Model Number 363706 |
Device Problems
Leak/Splash (1354); Component Misassembled (4004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2022 |
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 microtainer® map microtube for automated process k2 edta 1.0 mg customer state that the cap is loose and leakage occurred inside the bag during transportation.The following information was provided by the initial reporter.The customer stated: ¿it was reported by the customer that cap is loose and leakage occurred inside of bag during transportation.¿.
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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.Therefore, 50 retention samples were visually inspected with no issues being identified.Bd was unable to confirm the customer¿s indicated failure mode based on the investigation completed.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 microtainer® map microtube for automated process k2 edta 1.0 mg customer state that the cap is loose and leakage occurred inside the bag during transportation.The following information was provided by the initial reporter.The customer stated: ¿it was reported by the customer that cap is loose and leakage occurred inside of bag during transportation.¿.
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Search Alerts/Recalls
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