Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Septic Shock (2068)
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Event Date 09/10/2020 |
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 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.(b)(4).Medical device expiration date: unknown.The customer's address is unknown.(b)(6).Usa has been used as a default.The initial reporter also notified the fda on 1 june, 2020.Medwatch report # mw5094702 report source other: medwatch report.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¿ posiflush syringe may have been recalled.This was discovered during use.The following information was provided by the initial reporter: material no.Unknown batch no.Unknown it was reported that customer may have used a recalled syringe.Event description per email states: patient was admitted to hospital with sepsis on (b)(6) 2019 her port was removed because of the staff infection.Patient may have had a bd posiflush sf saline flush syringe as part of a port dressing change kit from the recalled lot numbers affected by the voluntary recall from bd.
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Manufacturer Narrative
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H.6.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
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Event Description
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It was reported that unspecified bd¿ posiflush syringe may have been recalled.This was discovered during use.The following information was provided by the initial reporter: material no.Unknown batch no.Unknown it was reported that customer may have used a recalled syringe.Event description per email states: patient was admitted to hospital with sepsis on (b)(6) 2019 her port was removed because of the staff infection.Patient may have had a bd posiflush sf saline flush syringe as part of a port dressing change kit from the recalled lot numbers affected by the voluntary recall from bd.
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Manufacturer Narrative
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The following fields have been updated with corrections: b.3.Date of event: 2020-(b)(6).The date received by manufacturer has been used for this field.G.4.Date received by manufacturer: 2020-09-10.
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Event Description
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It was reported that unspecified bd¿ posiflush syringe may have been recalled.This was discovered during use.The following information was provided by the initial reporter: material no.Unknown batch no.Unknown it was reported that customer may have used a recalled syringe.Event description per email states: patient was admitted to hospital with sepsis on (b)(6) 2019 her port was removed because of the staff infection.Patient may have had a bd posiflush sf saline flush syringe as part of a port dressing change kit from the recalled lot numbers affected by the voluntary recall from bd.
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Search Alerts/Recalls
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