Model Number 367884 |
Device Problems
Inability to Auto-Fill (1044); Short Fill (1575)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2022 |
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® lithium heparinn blood collection tubes had low draw and tube push off issue.This event occurred 50 times.The following information was provided by the initial reporter.The customer stated: during using the tube, it was found that the tube had low draw and tube push off issue.
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Event Description
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It was reported when using the bd vacutainer® lithium heparinn blood collection tubes had low draw and tube push off issue.This event occurred 50 times.The following information was provided by the initial reporter.The customer stated: ¿during using the tube, it was found that the tube had low draw and tube push off issue.¿.
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Manufacturer Narrative
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H.6.Investigation summary: material #: 367884.Lot/batch #: 1350354.Bd had not received samples or photos for evaluation.Therefore, ten (10) retention samples from bd inventory were visually inspected and functional testing was perform.No issues were observed relating to underfill or tube push off.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 of underfill and tube push off.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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Search Alerts/Recalls
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