Model Number 306507 |
Device Problem
Short Fill (1575)
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Patient Problem
Underdose (2542)
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Event Date 01/15/2020 |
Event Type
Injury
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this device may have been manufactured.A 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.No lot # provided.Device expiration date: unknown.Device manufacture date: unknown.
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Event Description
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It was reported that while using 0.9% normal saline 3ml fill in 3ml syringe, nursing staff became concerned the full volume was not being delivered when used in the hospital's bd alaris pump.When nursing staff tested the syringes, they found only 4ml was delivered when 6ml that was programmed into the bd alaris pump.No injury or deterioration in patient condition was reported related to underdosing.
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Event Description
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It was reported that while using 0.9% normal saline 3ml fill in 3ml syringe, nursing staff became concerned the full volume was not being delivered when used in the hospital's bd alaris pump.When nursing staff tested the syringes, they found only 4ml was delivered when 6ml that was programmed into the bd alaris pump.No injury or deterioration in patient condition was reported related to underdosing.
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Manufacturer Narrative
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The following field has been updated with corrected information: g.4.Date received by manufacturer: (b)(6) 2020.
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Manufacturer Narrative
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H.6.Investigation summary as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.No dhr review can be carried out as lot number is unknown.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.H3 other text : see section h.10.
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Event Description
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It was reported that while using 0.9% normal saline 3ml fill in 3ml syringe, nursing staff became concerned the full volume was not being delivered when used in the hospital's bd alaris pump.When nursing staff tested the syringes, they found only 4ml was delivered when 6ml that was programmed into the bd alaris pump.No injury or deterioration in patient condition was reported related to underdosing.
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Search Alerts/Recalls
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