Catalog Number 364314 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.E.1.Initial reporter facility name: (b)(6) hospital.
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Event Description
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It was reported that while using bd preset¿ arterial blood collection syringe, there was blood seeping out from piston of blood collection device.
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Manufacturer Narrative
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H.6 investigation summary: material #: 364314.Lot/batch #: 3024416.Bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with water, and no issues were observed relating to leakage 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 leakage.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 that while using bd preset¿ arterial blood collection syringe, there was blood seeping out from piston of blood collection device.
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Search Alerts/Recalls
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