Model Number 367290 |
Device Problems
Leak/Splash (1354); Defective Device (2588)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/17/2022 |
Event Type
Injury
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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.
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Event Description
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It was reported when using the bd vacutainer® multiple sample luer adapter the customer stated that device broke apart and sprayed blood in an employees face during use.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that while using the device it broke apart and sprayed blood in an employees face.
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Manufacturer Narrative
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Material #: 367290 lot/batch #: 2033250 bd had not received samples, but four (4) photos were provided for investigation.The photos were reviewed and the indicated failure mode for broken hub was observed.Additionally, thirty (30) retention samples from bd inventory were evaluated by visual examination and functional testing and the issue of broken hub was not observed.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 has been confirmed for the indicated failure mode broken hub.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.
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Event Description
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It was reported when using the bd vacutainer® multiple sample luer adapter the customer stated that device broke apart and sprayed blood in an employees face during use.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that while using the device it broke apart and sprayed blood in an employees face.
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Search Alerts/Recalls
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