Catalog Number 364356 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/17/2022 |
Event Type
malfunction
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Event Description
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It was reported when using the bd a-line¿, the device experienced the i.V.Shield cap coming off leaving the needle exposed.This event occurred two times.The following information was provided by the initial reporter.The customer stated: the customer reported that some packages contained no cap and the other packages contained an excess cap.
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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 a-line¿, the device experienced the i.V.Shield cap coming off leaving the needle exposed.This event occurred two times.The following information was provided by the initial reporter.The customer stated: the customer reported that some packages contained no cap and the other packages contained an excess cap.
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Manufacturer Narrative
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The following fields have been updated: device available for eval? yes.Returned to manufacturer on - 5/24/2022.H.6 investigation summary: "material #: 364356.Lot/batch #: 1291826.Bd received 6 samples for investigation.The samples were evaluated by visual examination and the indicated failure modes for extra and missing components with the incident lot was observed.Three pouches were observed to have extra end caps, one pouch was observed to have an extra syringe, and two pouches were observed to have missing end caps.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issues of extra and missing components were 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 modes extra and missing components.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends." h3 other text : see h10.
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Search Alerts/Recalls
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