Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Extravasation (1842); Phlebitis (2004); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/27/2021 |
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 (b)(6) has been listed and (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as no physical sample, part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Capa is not required at this time.
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Event Description
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It was reported that while using unspecified bd¿ venflon catheter the clinician encountered an infection on 8 occasions and extravasation on 15 occasions.The following information was provided by the initial reporter: it was reported via post market survey that clinicians encountered cannula related bloodstream infection (e.G.Blood stream bacteraemia, sepsis) (10), phlebitis (21), extravasation (not related to high pressure injection of contrast media) (15), and cannula occlusion (18).
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Search Alerts/Recalls
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