Catalog Number 306547 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/19/2019 |
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 that the plunger became detached while drawing 10 ml bd posiflush¿ normal saline syringe.Per email: reported issue: nurse was flushing a port during a blood draw and when she went to draw.Back her waste, she drew back 1ml worth of waste and the plastic plunger became detached.She set aside, got an empty syringe to draw back her waste and proceeded with no patient harm.
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Event Description
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It was reported that the plunger became detached while drawing 10 ml bd posiflush¿ normal saline syringe.Per email: reported issue: nurse was flushing a port during a blood draw and when she went to draw back her waste, she drew back 1ml worth of waste and the plastic plunger became detached.She set aside, got an empty syringe to draw back her waste and proceeded with no patient harm.
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Manufacturer Narrative
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Investigation summary: one sample was received.The plunger rod is not assembled to the rubber stopper, therefore failure mode is verified.Visual inspection was performed and no defect or deformations were noted.These syringes are one time use.After dispensing the saline solution they should be disposed of and shouldn¿t be used for withdrawing or any other application after expelling the saline solution.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.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.This is the 1st complaint for the lot# 8288922 for the same defect or symptom.There was no documentation of issues for the complaint of batch 8288922 during the production run.These syringes are one time use.After dispensing the saline solution they should be disposed of and shouldn¿t be used for withdrawing or any other application after expelling the saline solution.
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Search Alerts/Recalls
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