Catalog Number 301031 |
Device Problems
Contamination /Decontamination Problem (2895); Device Markings/Labelling Problem (2911)
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Patient Problem
Test Result (2695)
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Event Date 08/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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 luer-lok¿ syringes had foreign matter and scale marking error.There was no report of exposure, serious injury, or medical intervention.
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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 manufacture: no.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
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Event Description
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It was reported that bd luer-lok¿ syringes had foreign matter and scale marking error.There was no report of exposure, serious injury, or medical intervention.
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Search Alerts/Recalls
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