Catalog Number 364327 |
Device Problem
Missing Information (4053)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2023 |
Event Type
malfunction
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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 preset¿ abg syringe with luer-lok tip and attached needle there was missing scale label information.The following information was provided by the initial reporter.The customer stated: stage: before ready to use.Defect: it is found that the product has no scale.Quantity: 1 piece.Effects: no adverse effects.
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Manufacturer Narrative
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The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 2-may-2023.Investigation summary: bd received 1 sample for investigation.The sample was evaluated by visual examination and the indicated failure mode for missing scale markings with the incident lot was observed.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issue of missing 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 missing scale markings.Bd was not able to identify a root cause for the indicated failure mode.
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Event Description
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It was reported when using the bd preset¿ abg syringe with luer-lok tip and attached needle there was missing scale label information.The following information was provided by the initial reporter.The customer stated: stage: before ready to use.Defect: it is found that the product has no scale.Quantity: 1 piece.Effects: no adverse effects.
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Search Alerts/Recalls
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