Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Hematoma (1884); Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2021 |
Event Type
Injury
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Event Description
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It was reported that 7 unspecified bd¿ arterial cannulas caused localized infections during use.There was no report of patient impact.The following information was provided by the initial reporter: "it was reported via survey response the clinician experienced.Localized infection.When used for insertion"."it was reported via survey response the clinician experienced localized infection when used for arterial blood pressure monitoring"."it was reported via survey response the clinician experienced localized infection when used for serial arterial blood gas determination".
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Manufacturer Narrative
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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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Manufacturer Narrative
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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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that 7 unspecified bd¿ arterial cannulas caused localized infections during use.There was no report of patient impact.The following information was provided by the initial reporter: "it was reported via survey response the clinician experienced.Localized infection.When used for insertion"."it was reported via survey response the clinician experienced localized infection when used for arterial blood pressure monitoring"."it was reported via survey response the clinician experienced localized infection when used for serial arterial blood gas determination".
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Search Alerts/Recalls
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