Catalog Number 320468 |
Device Problems
Degraded (1153); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2022 |
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 bd ultra-fine¿ insulin syringe melted and was found in a sealed bag.The following information was provided by the initial reporter: my reason for emailing is i have found this odd syringe in my bag of syringes: as you can see the plunger is melted (or inserted wrong?) and was found in a sealed bag.
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Manufacturer Narrative
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H6: investigation summary customer returned an image of a 0.5ml, 30 gauge, 8mm syringe from lot 1340438.The side of the syringe features a black smudge that stretches from the 5 to the 15 unit graduation marks.This mark appears to be on the inside of the syringe barrel and ends approximately at the same location as the black stopper.A review of the device history record was completed for batch# 1340438.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the images received, embecta was able to confirm the customer¿s indicated failure of a stopper defect.Root-cause cannot be determined.H3 other text : see h10.
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Event Description
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It was reported that the bd ultra-fine¿ insulin syringe melted and was found in a sealed bag.The following information was provided by the initial reporter: my reason for emailing is i have found this odd syringe in my bag of syringes: as you can see the plunger is melted (or inserted wrong?) and was found in a sealed bag.
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Search Alerts/Recalls
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