Model Number 328440 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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 that bd insulin syringe with the bd ultra-fine¿ needle hub separated.This occurred on 2 occasions during use.The following information was provided by the initial reporter: material no.328440 batch no.9112704 it was reported that needle hub separated into needle shield on 2 syringes.Verbatim: consumer reported needle hub separated and stayed inside the shield, two syringes involved.Consumer does not re-use.
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Manufacturer Narrative
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H.6.Investigation: no samples (including photos) were returned as of 13 january 2020 therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 9112704.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were three (3) notifications [200821671, 200821662, 200821922] noted that did not pertain to the complaint.
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Event Description
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It was reported that bd insulin syringe with the bd ultra-fine¿ needle hub separated.This occurred on 2 occasions during use.The following information was provided by the initial reporter: material no.328440 batch no.9112704 it was reported that needle hub separated into needle shield on 2 syringes.Verbatim: consumer reported needle hub separated and stayed inside the shield, two syringes involved.Consumer does not re-use.
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Search Alerts/Recalls
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