Catalog Number 990629 |
Device Problem
Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2021 |
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that syringe 10ml 25mm 7dmm s/su nbs was illegible.This occurred on 3 occasions.The following information was provided by the initial reporter: unreadable descriptions (lot).The boxes came apparently intact and without any signal of wetting.
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Manufacturer Narrative
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H.6.Investigation: through the analysis of the photo sent by the customer, it is possible to observe the illegible printed batch.A device history review was performed for lot 1174961, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.The label review record, which is carried out to ensure correct printing of information, was analyzed and no defects were found.No request for reprinting of labels related to the claimed box was evidenced.Possible root cause is associated with an entanglement of the box in the part of the equipment that pulls the box for closing.H3 other text : see h.10.
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Event Description
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It was reported that syringe 10ml 25mm 7dmm s/su nbs was illegible.This occurred on 3 occasions.The following information was provided by the initial reporter: unreadable descriptions (lot).The boxes came apparently intact and without any signal of wetting.
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Search Alerts/Recalls
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