Catalog Number 326716 |
Device Problem
Missing Information (4053)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/15/2021 |
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 syringe 1ml 27ga 1/2in p experienced missing label information.The following information was provided by the initial reporter: 1 shipping carton has been rejected because its label is damaged, inside the protection.
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Event Description
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It was reported that the syringe 1ml 27ga 1/2in p experienced missing label information.The following information was provided by the initial reporter: 1 shipping carton has been rejected because its label is damaged, inside the protection.
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Manufacturer Narrative
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H.6.Investigation: no physical samples were received; the investigation was performed based on the photo provided.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.The claim is considered confirmed since the defect is reproducible in the cube formation process, so the failure mode: feeding boxes in the arpac machine, is confirmed.H3 other text : see h.10.
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Search Alerts/Recalls
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