Catalog Number 395000 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2023 |
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 that 100 bd connecta¿ stopcock 3-way experienced incorrect label information.The following information was provided by the initial reporter: received phone call from customer (distributor) said the cat.No.395000, bd connecta instead of three waystopcock it's mentioned as four-way stopcock without extension tube mentioned in the package label.
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Event Description
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It was reported that 100 bd connecta¿ stopcock 3-way experienced incorrect label information.The following information was provided by the initial reporter: received phone call from customer (distributor) said the cat.No.395000, bd connecta instead of three waystopcock it's mentioned as four-way stopcock without extension tube mentioned in the package label.
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Manufacturer Narrative
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H6: investigation summary: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of documentation error-label content incorrect was confirmed upon inspection of the sample photos.Analysis of the sample photos showed that the documentation referred to the product as a 4-way stopcock, when the physical product was confirmed to be a 3-way stopcock.Bd determined that the cause of the failure was associated to our manufacturing process, and we are currently working on a project to solve the reported defect from recurring.Production records were reviewed, and this batch meets our manufacturing specification requirements.
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Search Alerts/Recalls
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