BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE; BLOOD SPECIMEN COLLECTION DEVICE
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Catalog Number 364314 |
Device Problem
Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2023 |
Event Type
malfunction
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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 defective scale markings was observed.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issue of defective scale markings 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 defective scale markings.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
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Event Description
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It was reported when using the bd preset¿ arterial blood collection syringe there was smeared/smudged scale markings on the device where volumetrics are not readable.The following information was provided by the initial reporter.The customer stated: "4.12 after the blood gas syringe is opened, it is found that the scale is not printed clearly, and the blood volume cannot be judged, so it can only be discarded.".
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Search Alerts/Recalls
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