Catalog Number 304050 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: na.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 barrel 1cc s/t w/sil no bd logo/tb bns leaked blood at the needle connection while drawing an abg.The following information was provided by the initial reporter: "when drawing an abg the syringe plugger will not aspirate the sample correctly, and the blood sample leaks out at the needle connection.".
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Event Description
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It was reported that the barrel 1cc s/t w/sil no bd logo/tb bns leaked blood at the needle connection while drawing an abg.The following information was provided by the initial reporter: "when drawing an abg the syringe plugger will not aspirate the sample correctly, and the blood sample leaks out at the needle connection.".
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Manufacturer Narrative
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H.6.Investigation: since no samples displaying the reported condition were received the reported defect could not be confirmed.A device history record review was completed for provided lot number 0233244.A review showed insufficient silicone issue was reported during the production.Product was requalified per applicable acceptable quality limit before production resumed.
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Search Alerts/Recalls
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