Catalog Number UNKNOWN |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/10/2020 |
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.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¿ introsyte introducer package was damaged.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via introsyte introducer survey that the clinician experienced introducer was difficult to thread and package seal not intact before use (breach in package integrity).
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Manufacturer Narrative
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H6.Investigation: bd was unable to perform a thorough investigation as no material number, sample, lot, or batch number were provided.Dhr could not be performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h10.
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Event Description
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It was reported that unspecified bd¿ introsyte introducer package was damaged.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via introsyte introducer survey that the clinician experienced introducer was difficult to thread and package seal not intact before use (breach in package integrity).
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Search Alerts/Recalls
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