Catalog Number 367839 |
Device Problem
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 12/09/2021 |
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® k2e 7.2mg plus blood collection tube there was stopper pull out of the tube within the holder.The following information was provided by the initial reporter.The customer stated: there was an issue with the purple top vacutainers as they are leaking blood." additional information provided (b)(6) 2021: the customer stated: "d (initial) had blood on her hands, i personally did not come into direct contact with the blood from my patient.The sample i took was still sent to the labs as it was cleaned and checked for any further leakage.It appears that the self-sealing bung was slow to seal after being removed from the vacutainer needle." there were no reports of medical interventions or testing.
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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 stopper pull out of the tube within the holder.The following information was provided by the initial reporter.The customer stated: there was an issue with the purple top vacutainers as they are leaking blood." additional information provided 2021-12-17: the customer stated: "d (initial) had blood on her hands, i personally did not come into direct contact with the blood from my patient.The sample i took was still sent to the labs as it was cleaned and checked for any further leakage.It appears that the self-sealing bung was slow to seal after being removed from the vacutainer needle." there were no reports of medical interventions or testing.
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Manufacturer Narrative
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H.6.Investigation: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by functional testing- cap/stopper assemblies were removed and reattached, and samples were left to stand for 3 hours.None of the cap/stopper assemblies detached from their tubes during the procedure.No issues were observed relating to cap /stopper assemblies and 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 cap /stopper assemblies and 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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