Catalog Number UNKNOWN |
Device Problem
Packaging Problem (3007)
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Patient Problem
Thrombosis (2100)
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Event Date 01/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: (b)(4).Medical device expiration date: unknown.Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
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Event Description
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It was reported that unspecified bd¿ catheter had foreign matter.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via post market survey that the clinician encountered occurrences of needle through catheter (1), foreign matter (1), and thrombosis (1).
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Manufacturer Narrative
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H6: investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history record review could not be performed because a model or lot number was not provided by the customer.
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Event Description
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It was reported that unspecified bd¿ catheter had foreign matter.The following information was provided by the initial reporter: material no: unknown; batch no: unknown.It was reported via post market survey that the clinician encountered occurrences of needle through catheter (1), foreign matter (1), and thrombosis (1).
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Search Alerts/Recalls
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