Catalog Number 394605 |
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 01/03/2023 |
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 the outer packaging of the bd connecta¿ stopcock had the lot labeled as 2091994, while the inner label listed it as 2091994b.This occurred with 5000 products.The following information was provided by the initial reporter, translated from chinese: "at the distributor, when entering the platform, it was found that the batch number of the product package was inconsistent with the batch number of the internal product.Outer packaging batch number: 2091994; internal product batch number: 2091994b.".
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Event Description
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It was reported that the outer packaging of the bd connecta¿ stopcock had the lot labeled as 2091994, while the inner label listed it as 2091994b.This occurred with 5000 products.The following information was provided by the initial reporter, translated from chinese: "at the distributor, when entering the platform, it was found that the batch number of the product package was inconsistent with the batch number of the internal product.Outer packaging batch number: 2091994; internal product batch number: 2091994b.".
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Manufacturer Narrative
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H6.Investigation summary: bd was not able to confirm the customer¿s indicated failure mode because samples or pictures were not provided to perform better investigation.A device history record review as completed for provided material number 394605, lot 2091994.The product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.There were no nonconformance(s) or abnormal conditions noted at the time of production.This condition is normal in the nogales manufacturing process since a letter is placed at the end of the batch of the unit package which indicates the shift in which the batch of product is manufactured.This is by requirement of our packaging procedure pg-172sp which mentions that the product must contain this letter.
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Search Alerts/Recalls
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