Catalog Number 990558 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/29/2021 |
Event Type
malfunction
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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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported when using the bd ser plastipak 10ml s ls, the device experienced missing scale markings.This event occurred 44 times.The following information was provided by the initial reporter.The customer stated: we found that some 10ml bd syringes from lot 1105299 came ungraded.I separated from my inventory the ones that had this error, totaling 44 units.
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Manufacturer Narrative
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H6: investigation summary: photo received for investigation.Upon visual inspection, it is possible to observe missing scale marking on the syringe.Possible root cause, is related to a failure of the paint pump.Paint pump was repaired immediately after notification.A device history review was conducted for lot number 1105299.
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Event Description
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It was reported when using the bd bd ser plastipak 10ml s ls, the device experienced missing scale markings.This event occurred 44 times.The following information was provided by the initial reporter.The customer stated: we found that some 10ml bd syringes from lot 1105299 came ungraded.I separated from my inventory the ones that had this error, totaling (b)(4) units.
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Search Alerts/Recalls
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