BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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Catalog Number 368498 |
Device Problem
Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2022 |
Event Type
malfunction
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Event Description
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It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes was uncapped during transport.The following information was provided by the initial reporter.The customer stated: the tube was uncapped during transport to the laboratory.When they received the samples from one plant in the laboratory, the tube had been uncapped during transport, resulting in the loss of the sample.They then checked the rest of the tubes from the plant where the sample had been taken and found that there were more tubes where the cap was moving, so they decided to withdraw the rest of the tubes from the lot from the entire hospital and from the primary care centres.
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Manufacturer Narrative
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Investigation summary: bd had not received samples, but two (2) photos were provided for investigation.Evaluation of the photographs attached shows one uncapped sst tube.The photos were reviewed and the indicated failure mode for stopper pop off and stopper creep out was observed.Additionally, ten (10) retention samples from bd inventory were evaluated by functional testing and the issue of underfill 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 and stopper creep out.
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Search Alerts/Recalls
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