Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Extravasation (1842); Unspecified Infection (1930)
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Event Date 01/26/2021 |
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 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 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.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 extravasation and an infection occurred after using unspecified bd¿ catheter.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported via post market survey that the clinician encountered occurrences of localized iv site infections (e.G.Cellulitis, abscess, phlebitis, thrombophlebitis) (5) and infiltration / extravasation (5).
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Event Description
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It was reported that extravasation and an infection occurred after using unspecified bd¿ catheter.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via post market survey that the clinician encountered occurrences of localized iv site infections (e.G.Cellulitis, abscess, phlebitis, thrombophlebitis) (5) and infiltration / extravasation (5).
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Manufacturer Narrative
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H.6.Investigation: bd was unable to perform a thorough investigation as no 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.
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Search Alerts/Recalls
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