Catalog Number 367962 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D.4.Medical device expiration date: unknown h.3.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.H.4.Device manufacture date: unknown.
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Event Description
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It has been reported that the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tube has been found being used after expiration.No patient impact was reported.The following has been provided by the initial reporter: 1 patient sample was collected with an expired tube (approximately 1-2 months past expiration), customer states testing results seemed to be in range, matching previous patient results.
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed for the indicated failure mode of using a tube past expiration.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.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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Event Description
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It has been reported that the bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tube has been found being used after expiration.No patient impact was reported.The following has been provided by the initial reporter: 1 patient sample was collected with an expired tube (approximately 1-2 months past expiration), customer states testing results seemed to be in range, matching previous patient results.
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Search Alerts/Recalls
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