Catalog Number 328506 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device expiration date: n/a.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 a bd ultra-fine¿ insulin syringe had a missing shield and bent needle.There was no report of exposure, serious injury or medical intervention.
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Event Description
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It was reported that a bd ultra-fine¿ insulin syringe had a missing shield and bent needle.There was no report of exposure, serious injury or medical intervention.
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Manufacturer Narrative
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Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 8036925.All inspections were performed per the applicable operations qc specifications.There was one (1) notification (b)(4) noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time investigation conclusion: unable to determine a root cause.Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.
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Search Alerts/Recalls
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