Catalog Number 367300 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: 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 when using the bd vacutainer® multiple sample luer adapter blood collection could not be performed.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: difficulties with blood collection using luer adapter.The blood collection could not be performed.
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination with a borescope, which shines light through the needle to check for any clogs, and no issues were observed relating to clogged 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 clogged.Bd was not able to identify a root cause for the indicated failure mode.
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Event Description
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It was reported when using the bd vacutainer® multiple sample luer adapter blood collection could not be performed.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: ¿difficulties with blood collection using luer adapter.The blood collection could not be performed.¿.
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Search Alerts/Recalls
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