Catalog Number UNKNOWN |
Device Problems
Leak/Splash (1354); Packaging Problem (3007)
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Patient Problem
Exposure to Body Fluids (1745)
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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: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.The customer's address is unknown.(b)(6) usa has been used as a default.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 and the clinician experienced blood exposure.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.
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Manufacturer Narrative
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H.6.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#.
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Event Description
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It was reported that unspecified bd¿ introsyte introducer package was damaged and the clinician experienced blood exposure.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.
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Search Alerts/Recalls
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