Catalog Number 367861 |
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 01/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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D.4.Medical device expiration date: unknown.H3: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4: device manufacture date: unknown.
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Event Description
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It was reported that the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes have been used after the expiration date.There was no report of patient impact.
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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.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Bd does not have any data claims for use of the product beyond the expiration date.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 was reported that the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes have been used after the expiration date.There was no report of patient impact.
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Search Alerts/Recalls
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