Catalog Number 393234 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Phlebitis (2004)
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Event Date 08/04/2023 |
Event Type
Injury
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Event Description
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It was reported that adverse event occurred while the bd venflon¿ pro safety was used.Report 1 of 2.The following was received by the initial reporter: complained having incidences of phlebitis and thrombophlebitis with venflon pro cannula leading to removal of cannula before 2 days.
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Manufacturer Narrative
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The manufacturing location for this product is (b)(6).This site is not registered with the fda.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.E.1.Initial reporter phone #: (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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H6: investigation summary no samples (including photos) were returned for the reported issue of ¿irritation/ inflammation and phlebitis¿ with lot number 2055123 regarding material number 393234, so retention samples were used for the investigation.The device history review (dhr) of material number 393234 with lot number 2055123 was checked and there was no quality notification found on this lot number from its production date to its dispatch on date.The investigation and simulation were carried out on retention samples.A sterility test is performed before release of lot number 2055123.The investigating team has found all results are within specification and no defect was found in finished goods testing result.The exact root cause can only be determined if we receive the original sample.The root cause cannot be determined.See h10.
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Event Description
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It was reported that adverse event occurred while the bd venflon¿ pro safety was used.Report 1 of 2.The following was received by the initial reporter: complained having incidences of phlebitis and thrombophlebitis with venflon pro cannula leading to removal of cannula before 2 days.
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Search Alerts/Recalls
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