Catalog Number 301746 |
Device Problems
Break (1069); 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 11/15/2022 |
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.
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Event Description
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It was reported when using the bd vacutainer® flashback blood collection needle the needle is broken and is difficult to be removed in the holder and has foreign matter on the tip of the needle.The following information was provided by the initial reporter.The customer stated: "the cap of the blood collection tube is broken during blood collection, the blood needle is broken and cannot be removed in the needle holder, the bevel of the needle tip of the blood collection needle is short, and there are foreign objects.".
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Event Description
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It was reported when using the bd vacutainer® flashback blood collection needle the needle is broken and is difficult to be removed in the holder, and has foreign matter on the tip of the needle.The following information was provided by the initial reporter.The customer stated: "the cap of the blood collection tube is broken during blood collection, the blood needle is broken and cannot be removed in the needle holder, the bevel of the needle tip of the blood collection needle is short and there are foreign objects.".
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples or photos for evaluation.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 modes damaged needle point, and foreign matter.Bd was not able to identify a root cause for the indicated failure modes.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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Search Alerts/Recalls
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