Catalog Number 302995 |
Device Problem
Moisture Damage (1405)
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Patient Problem
No Information (3190)
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Event Date 06/29/2018 |
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.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 bd syringe luer-lok¿ tip contained moisture or droplets.No serious injury or medical intervention reported.
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Event Description
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It was reported that bd syringe luer-lok¿ tip contained moisture or droplets.No serious injury or medical intervention reported.
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Manufacturer Narrative
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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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Manufacturer Narrative
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One photo was received depicting a loose 10ml syringe and 4 packages from catalog #302995.Product reported to be from batch #8033684.There was no visible moisture in the syringe the photo, the reported defect was not identified in the photo received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that bd syringe luer-lok tip contained moisture or droplets.No serious injury or medical intervention reported.
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Search Alerts/Recalls
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