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Catalog Number 627831 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported two (2) oral syringes had a printing issue.The numeral four (4) of the graduation markings was missing.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: two (2) devices were received for evaluation.During visual inspection the text and graduation markings were missing print on both syringe barrels.The reported condition was verified.The cause of the condition could not be determined; however, the defect is most likely related to variability in the screen printing and curing process during manufacturing.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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