Catalog Number 328431 |
Device Problems
Leak/Splash (1354); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd insulin syringes with bd ultra-fine¿ needle there was a hole in the barrel and insulin leaked.This occurred 6 times.There was no report of patient impact.The following information was provided by the initial reporter: consumer/pet owner reported finding about 6 syringes from this box with holes in barrel.Found when drawing and also injecting.Can see the insulin coming out side of barrel syringe.
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Manufacturer Narrative
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H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 2094869.All inspections were performed per the applicable operations qc specification.There were zero (0) notifications noted that did not pertain to the complaint.H3 other text : see h10.
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Event Description
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It was reported while using bd insulin syringes with bd ultra-fine¿ needle there was a hole in the barrel and insulin leaked.This occurred 6 times.There was no report of patient impact.The following information was provided by the initial reporter: consumer/pet owner reported finding about 6 syringes from this box with holes in barrel.Found when drawing and also injecting.Can see the insulin coming out side of barrel syringe.
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Search Alerts/Recalls
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