Catalog Number 309605 |
Device Problem
Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2023 |
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 bd luer-lok¿ tip syringe in the bulk sterile convenience pak scale markings had excessive ink that created rings around the barrel, rendering the product illegible.The following information was provided by the initial reporter: "during visual inspection on 01/18/23 there were syringes with excessive ink from the graduation marks that created rings around the entire syringe".
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Event Description
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It was reported that the bd luer-lok¿ tip syringe in the bulk sterile convenience pak scale markings had excessive ink that created rings around the barrel, rendering the product illegible.The following information was provided by the initial reporter: "during visual inspection on 01/18/23 there were syringes with excessive ink from the graduation marks that created rings around the entire syringe".
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Manufacturer Narrative
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H6: investigation summary six samples and seven photos were provided to our quality team for investigation.Through visual inspection, it was observed that three of the samples have a double image on the numbers and bd logo of the scale markings, however; the markings are legible.Three of the samples have missing print in the scale markings area on the numbers and major and minor graduation lines consistent with being scraped off.One of the photos shows a loose syringe have five hairline ink rings in the scale markings area of the barrel.The ink rings and missing print conditions observed are non-conforming per product specification.Potential root cause for the ink ring defect is associated with the marking process and missing print is associated with the assembly process.A notification for these defects were written during the production of this batch.A requalification was performed, and the line cleared of defects.However, it is possible a limited number of pieces with this condition were able to escape detection.These.
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Search Alerts/Recalls
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