Model Number 329406 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2021 |
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.Medical device expiration date: na.Initial reporter state: address information was not able to be obtained, however, nj was used as a place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the expiration date was missing on shelf pack with a bd ultra-fine¿ insulin syringes, 1ml 30g x 1/2.The following information was provided by the initial reporter: it was reported that expiration date was not on shelf carton.Consumer wanted to know if syringes were still good to use.Stated, did not see expiration date.
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Event Description
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It was reported that the expiration date was missing on shelf pack with a bd ultra-fine¿ insulin syringes, 1ml 30g x 1/2.The following information was provided by the initial reporter: it was reported that expiration date was not on shelf carton.Consumer wanted to know if syringes were still good to use.Stated, did not see expiration date.
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Manufacturer Narrative
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H.6.Investigation: 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# 6312688.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.This batch was manufactured before expiration dates were printed on packaging.
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Search Alerts/Recalls
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