Catalog Number 383078 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 11/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter phone #: unknown.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 that during infusion patient started to convulse with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: it was happened during the usage of infusion, and the damaged performance was convulsion.
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Event Description
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It was reported that during infusion patient started to convulse with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: it was happened during the usage of infusion, and the damaged performance was convulsion.
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Manufacturer Narrative
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H.6.Investigation summary: unfortunately the provided lot number could not be associated with any becton dickinson products.Since a valid lot number could not be connected to the device identified in the complaint, bd investigators could not conduct a device history review for this event.Additionally, a sample has not yet been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in your description of the event.Examination of the product involved may provide clarification as to the cause for the reported failure.Root cause description: no sample, no lot h3 other text : see h.10.
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Search Alerts/Recalls
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