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 11/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that while using bd preset¿ arterial blood collection syringe, the scale markings on one syringe were illegible.No patient impact reported.
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Manufacturer Narrative
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H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that while using bd preset¿ arterial blood collection syringe, the scale markings on one syringe were illegible.No patient impact reported.
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Manufacturer Narrative
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H.6 investigation summary material #: 364314.Lot/batch #: 3087214.Bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to illegible scale markings as all samples met specifications.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 is unable to be confirmed for the indicated failure mode illegible scale markings.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.
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Search Alerts/Recalls
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