BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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Model Number 367955 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); 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 11/22/2022 |
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 vacutainer® sst¿ ii advance plus blood collection tube there was poor barrier separation of the sample, red cell hang up, and missing additive.The following information was provided by the initial reporter.The customer stated: "sub-optimal separation is always present, which forced the batch change in order to avoid equipment problems.Probable reactivity to serological tests for hcv has been ruled out, not attributable to the tubes.Non-optimal separation - after centrifugation of the samples, the serum shows traces of red blood cells and fibrin filaments; probable reactivity to serological tests for hcv.A higher percentage of false positives for hcv was found 27 reactants in october out of 4222 or 0.64%, 4 reagents in september out of 4329 or 0.09%.".
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Event Description
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It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was poor barrier separation of the sample, red cell hang up, and missing additive.The following information was provided by the initial reporter.The customer stated: "sub-optimal separation is always present, which forced the batch change in order to avoid equipment problems.Probable reactivity to serological tests for hcv has been ruled out, not attributable to the tubes.Non-optimal separation - after centrifugation of the samples, the serum shows traces of red blood cells and fibrin filaments; probable reactivity to serological tests for hcv.A higher percentage of false positives for hcv was found 27 reactants in october out of 4222 or 0.64%, 4 reagents in september out of 4329 or 0.09%.".
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for red cell hang up was observed, however fibrin and poor barrier separation was not observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, the indicated failure mode for red cell hang up and poor barrier separation was not observed.There were no difficulties encountered during blood collection and all tubes exhibited proper fill.Bd was unable to duplicate the customer¿s indicated failure modes of poor barrier separation and red cell hang up, because the defects were not evident in the testing of the complaint lot samples.However bd is able to duplicate the customer's indicated failure mode of fibrin as fibrin strands were visually present in the retain and control samples.All visual observations of both retain and control samples tested demonstrated clinically acceptable performance except with respect to fibrin.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 red cell hang up and fibrin.This complaint is has not been confirmed for poor barrier separation.Bd was not able to identify a root cause for the indicated failure mode.
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