Catalog Number 367342 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/08/2018 |
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 that after using a bd vacutainer® push button blood collection set "the needle is not retracting rather the spring is ejecting." no report of serious injury or medical intervention.
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Event Description
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It was reported that after using a bd vacutainer® push button blood collection set "the needle is not retracting rather the spring is ejecting." no report of serious injury or medical intervention.
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Manufacturer Narrative
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Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the manufacturing records was completed for the incident lot and no issues were identified.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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