Model Number 364902 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 luer-lok¿ access device (male luer) there was blood leakage or other sample leakage from the device other than the insertion site or needle tip.The following information was provided by the initial reporter.The customer stated: "there is leaking at the needle while changing tubes.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 2022-11-18.H.6.Investigation summary: h.6.Investigation summary: bd received 5 samples and 3 photos for investigation.The photos were reviewed and the indicated failure mode for leakage with the incident lot was not observed.Two of the photos only show product labeling and the third photo is not clear enough to see any leakage / defects.The customer samples were evaluated by visual examination and 3 of the samples by functional leakage testing and the indicated failure mode for leakage with the incident lot was not observed as all product specifications were met.Additionally, 48 retention samples from bd inventory were evaluated by visual examination and 12 retention samples by functional leakage 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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Event Description
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It was reported when using the bd luer-lok¿ access device (male luer) there was blood leakage or other sample leakage from the device other than the insertion site or needle tip.The following information was provided by the initial reporter.The customer stated: "there is leaking at the needle while changing tubes.".
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Search Alerts/Recalls
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