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Model Number 405675 |
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 06/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 tray spn whit25g3.5 25g1.5 l/b-d/e was labeled incorrectly, with fill markings incorrectly placed.The following information was provided by the initial reporter: "hash marks on 5ml syringe in epidural kit do not line up with the hub/base of the syringe.This could have resulted in delivering approx 1ml additional medication than intended.Anesthesiologist, dr , noted issue upon drawing up medication and handed off mis-marked syringe immediately.New kit opened--same manuf number, same lot number but the syringe within was correct.".
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Event Description
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It was reported tray spn whit25g3.5 25g1.5 l/b-d/e was labeled incorrectly, with fill markings incorrectly placed.The following information was provided by the initial reporter: "hash marks on 5ml syringe in epidural kit do not line up with the hub/base of the syringe.This could have resulted in delivering approx 1ml additional medication than intended.Anesthesiologist, dr , noted issue upon drawing up medication and handed off mis-marked syringe immediately.New kit opened--same manuf number, same lot number but the syringe within was correct.".
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Manufacturer Narrative
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Correction: the following fields were corrected: d4: medical device lot #: unknown.The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-01-27.H6: investigation summary: one physical sample was returned to our quality team for investigation.Through visual inspection, it was observed that the syringe markings did not line up properly with the base of the syringe therefore, the reported failure mode was confirmed.A device history review could not be completed as no batch number was provided.Based on the available information, the root cause of the issue correspond to a supplier defect, scar was issued to the supplier complaints received for this device and reported condition will continue to be tracked and trended.
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Search Alerts/Recalls
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