Catalog Number 302204 |
Device Problems
Degraded (1153); Volume Accuracy Problem (1675); Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 2ml ls was cracked.The following information was provided by the initial reporter: not sealed, crack in outer casing, some numbers/markers are missing.
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Event Description
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It was reported that syringe 2ml ls was cracked.The following information was provided by the initial reporter: not sealed, crack in outer casing, some numbers/markers are missing.
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Manufacturer Narrative
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H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
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Search Alerts/Recalls
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