Catalog Number 328512 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/10/2018 |
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.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# 8071777.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description : root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
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Event Description
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It was reported that plunger cap of bd¿ insulin syringe was cracked.
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Manufacturer Narrative
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In section h.10 of the previously submitted mdr, sections d.1 was incorrectly referenced as the medical device expiration date.This supplemental mdr is being submitted to correct those references to show the following:.
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Event Description
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It was reported that plunger cap of bd¿ insulin syringe was cracked.
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Search Alerts/Recalls
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