Catalog Number 309648 |
Device Problem
Inaccurate Information (4051)
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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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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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Event Description
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It was reported that 3 bd luer-lok¿ syringes had crooked scale markings.This complaint was created to capture the 4th of 6 related incidents.The following information was provided by the initial reporter, translated from dutch: "crooked scale x 3.".
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Event Description
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It was reported that 3 bd luer-lok¿ syringes had crooked scale markings.This complaint was created to capture the 4th of 6 related incidents.The following information was provided by the initial reporter, translated from dutch: "crooked scale x 3".
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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 three samples were received in a separate bag with a claim of crooked scale.After inspection, it was observed that all the three samples had skewed scale greater than 0.05 degree.Potential root cause for skewed scale print 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.H3 other text : see h10.
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Search Alerts/Recalls
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