Catalog Number 302100 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/05/2021 |
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 print color on 5 syringe 1ml ls tuberculin blister packs ranged between black and brown.The following information was provided by the initial reporter, translated from (b)(6) to english: "this is a report about a printing issue on package.According to the customer's report, the prints on some packages are black and the prints on the other packages are brown.".
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Event Description
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It was reported that the print color on 5 syringe 1ml ls tuberculin blister packs ranged between black and brown.The following information was provided by the initial reporter, translated from japanese to english: "this is a report about a printing issue on package.According to the customer's report, the prints on some packages are black and the prints on the other packages are brown.".
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Manufacturer Narrative
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H.6.Investigation: two photos were received by our quality team for evaluation.From the photos, color change was observed in the top web graphic printing and batch number ¿0157812¿ and ¿0167922¿ is indicated.However, the correct batch numbers are ¿0157814¿ and ¿0167927¿.A device history record review found no non-conformances associated with this issue during production of this batch.The past year of syringe processes were reviewed and there was no change in the material used.The quality team has engaged with r&d on this complaint; however, the root cause could not be determined.A toxicology test was performed, and the acceptance criteria was met.
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Search Alerts/Recalls
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