BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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Catalog Number 367955 |
Device Problems
Coagulation in Device or Device Ingredient (1096); Device Ingredient or Reagent Problem (2910)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2022 |
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, the device experienced poor barrier separation of sample and red cell hang up.This event occurred once.The following information was provided by the initial reporter.The customer stated: we note an abnormally long sedimentation,(clarified as taking longer than 30 minutes - pw (b)(6) 2022) after centrifugation, presence of fibrin and red blood cell filaments.
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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® sst¿ ii advance plus blood collection tubes, the device experienced poor barrier separation of sample and red cell hang up.This event occurred once.The following information was provided by the initial reporter.The customer stated: we note an abnormally long sedimentation,(clarified as taking longer than 30 minutes - pw 14nov2022).After centrifugation, presence of fibrin and red blood cell filaments.
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure mode for red cell hang up was observed.Additionally, 6 retained samples were sent to winnersh for clinical evaluation.A complaint history review was performed and revealed a confirmed complaint trend for certain sample quality issues.Based on the confirmed complaint trend a capa (corrective and preventive action) was initiated.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 red cell hang up, poor clot formation, and fibrin based on the trend identified.A corrective and preventive action was created to address the issue.
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Search Alerts/Recalls
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