Catalog Number UNKNOWN |
Device Problem
Complete Blockage (1094)
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Patient Problems
Embolism (1829); Hemolysis (1886); Foreign Body Embolism (4439)
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Event Date 01/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used.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.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¿ q-syte was blocked on 40 occasions.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.It was reported via post market survey that there were occurrences of hemolysis (15), flow rate occluded (40) and particulate embolisms (30).
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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 review could not be completed as no batch number was provided.
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Event Description
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It was reported that unspecified bd¿ q-syte was blocked on 40 occasions.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via post market survey that there were occurrences of hemolysis (15), flow rate occluded (40) and particulate embolisms (30).
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Search Alerts/Recalls
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