Model Number 368650 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Date of event: unknown.The date received by manufacturer has been used for this field.
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Event Description
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It was reported when using the bd vacutainer® eclipse¿ blood collection needle with pre-attached holder customer found white/green foreign matter on the needle.The following information was provided by the initial reporter.The customer stated: "it was reported by the customer that there was a white/green dust on the needle during use.".
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Manufacturer Narrative
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Bd had not received samples or photos for investigation.Therefore, 30 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to foreign matter as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode foreign matter.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
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Event Description
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It was reported when using the bd vacutainer® eclipse¿ blood collection needle with pre-attached holder customer found white/green foreign matter on the needle.The following information was provided by the initial reporter.The customer stated: "it was reported by the customer that there was a white/green dust on the needle during use.".
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Search Alerts/Recalls
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