Catalog Number 368856 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2022 |
Event Type
malfunction
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Event Description
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It was reported when using the bd vacutainer® k3e plus blood collection tubes, the device experienced stopper creep out.The following information was provided by the initial reporter.The customer stated: cap of steel tube had come off while mixing back and forth.Cap fell on the ground during donation.Actions already taken: new steel tube filled.
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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® k3e plus blood collection tubes, the device experienced stopper creep out.The following information was provided by the initial reporter.The customer stated: cap of steel tube had come off while mixing back and forth.Cap fell on the ground during donation.Actions already taken: new steel tube filled.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-02-16.Investigation summary: bd received one contaminated sample and one photos for investigation.The photos were reviewed and the indicated failure mode for cap/stopper assembly was observed.One contaminated samples were received from the customer in support of this complaint and was disposed immediately.Plant does not examine contaminated samples.Additionally,10 retention samples from bd inventory, were evaluated by functional testing and the issue of stopper pop off was not observed.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 has been confirmed for the indicated failure mode stopper pop off.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h10.
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Search Alerts/Recalls
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