Catalog Number 367839 |
Device Problems
Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1270071.Medical device expiration date: 2023-01-31.Device manufacture date: 2021-09-27.Medical device lot #: 1284692.Medical device expiration date: unknown.Device manufacture date: unknown.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® k2e 7.2mg plus blood collection tube there was sample leakage.The following information was provided by the initial reporter.The customer stated: "three tubes have either had the caps leak or were broken upon receipt in the laboratory.".
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Event Description
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It was reported when using the bd vacutainer® k2e 7.2mg plus blood collection tube there was sample leakage.The following information was provided by the initial reporter.The customer stated: "three tubes have either had the caps leak or were broken upon receipt in the laboratory.".
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Manufacturer Narrative
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H6: investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by functional draw testing and no issues were observed relating to leakage as all samples met specifications.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 leakage.Bd was not able to identify a root cause for the indicated failure mode.
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Search Alerts/Recalls
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