Catalog Number UNKNOWN |
Device Problems
Excess Flow or Over-Infusion (1311); Defective Component (2292)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/27/2022 |
Event Type
malfunction
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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.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the unspecified bd¿ syringe had difficult plunger movement.Additionally, the dexmedetomidine infused a full 3ml when only.5ml should have been infused.The following information was provided by the initial reporter: "event 1: date of event: (b)(6) 2022 @ 03:00.Description of event: channel did not have the total amount infused visible at 03:00.Patient injury: no.Model/brand and size of syringe: bd 60ml syringe.If a syringe malfunction, what channel: d.Medication being infused and rate/total volume: dexmedetomidine, rate: 0.2mls/hr, total volume should have been 0.8mls.Was there additional medical intervention to the patient: switched to different channel on different brain."it infused a full 3ml when it should have infused.5ml is all i know.".
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Manufacturer Narrative
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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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No additional information.
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Search Alerts/Recalls
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