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Model Number IPN043749 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/19/2022 |
Event Type
malfunction
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Event Description
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It was reported that: "while using the filter, the filter opened in 2 pieces and you could touch the inside.Due to the yellow sticker, it was masked, and it took a while that they found out where the leak came from".No patient injury or harm reported.Patient condition reported as "fine".
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Manufacturer Narrative
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Qn#(b)(4).
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Manufacturer Narrative
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Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the filter was split in two.The complaint has been confirmed.A device history record review was performed and no relevant findings were identified.The manufacturing site reports that the issue is supplier related and a non-conformance was opened to address the issue.
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Event Description
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It was reported that: "while using the filter, the filter opened in 2 pieces and you could touch the inside.Due to the yellow sticker, it was masked, and it took a while that they found out where the leak came from".No patient injury or harm reported.Patient condition reported as "fine".
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Search Alerts/Recalls
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