Model Number 367342 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2022 |
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® push button blood collection set tubing is cut on product.The following information was provided by the initial reporter.The customer stated: "it was reported that bd vacutainer® push button blood collection set tubing is cut on product.".
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Event Description
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It was reported when using the bd vacutainer® push button blood collection set tubing is cut on product.The following information was provided by the initial reporter.The customer stated: "it was reported that bd vacutainer® push button blood collection set tubing is cut on product.".
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Manufacturer Narrative
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H.6.Investigation summary: catalog number: 367342.Batch number: 2117572.Bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure mode for cut tubing was observed.Additionally, 30 retention samples from bd inventory were evaluated by visual examination and the issue of cut tubing 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 cut tubing.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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