Catalog Number 301746 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1.Initial reporter facility name: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that while using bd vacutainer® flashback blood collection needle, there is blood leakage at the sleeve of two (2) devices.No patient impact reported.
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Event Description
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It was reported that while using bd vacutainer® flashback blood collection needle, there is blood leakage at the sleeve of two (2) devices.No patient impact reported.
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Manufacturer Narrative
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H.6.Investigation summary: material #: 301746 lot/batch #: 3145994 bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for leakage was 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 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.
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Search Alerts/Recalls
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