Catalog Number 309648 |
Device Problem
Melted (1385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2022 |
Event Type
malfunction
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Event Description
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It was reported that the tip of the bd luer-lok¿ syringe was melted.This complaint was created to capture the 6th of 6 related incidents.The following information was provided by the initial reporter, translated from dutch: "melted tip x 1".
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 18-jan-2023.H6: investigation summary: one sample was received in a separate bag with a claim of melted tip.After inspection, it was observed that the sample had a deformed tip in which some portion of the barrel¿s tip is melted.Potential root cause for the barrel tip deformation defect with the marking process.A device history record review was completed for provided lot number 1331232.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
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Event Description
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It was reported that the tip of the bd luer-lok¿ syringe was melted.This complaint was created to capture the 6th of 6 related incidents.The following information was provided by the initial reporter, translated from dutch: "melted tip x 1".
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Search Alerts/Recalls
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