Catalog Number 42081E |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd alaris smartsite gravity blood set tubing clamp was missing.The following information was provided by the initial reporter: customer reported that the tubing is missing a clamp.
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Manufacturer Narrative
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H3.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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Manufacturer Narrative
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H6: investigation summary one sample was received for quality investigation.The customer complaint of misassembly was verified by visual inspection.Visual inspection of the sample received, and comparison of the build of material of the material number, indicate that there is a missing roller clamp from the tubing below the drip chamber.A device history record review for model 42081e lot number 23029232 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of the failure seen in the sample is that the roller clamp was not added to the full assembly during the manufacturing process due to a failure of the assembler not using the proper fixture.Further investigation indicated that the assembly fixture was not used due to it being damaged and/or inverted.H3 other text : see h10.
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Event Description
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It was reported that the bd alaris smartsite gravity blood set tubing clamp was missing.The following information was provided by the initial reporter: customer reported that the tubing is missing a clamp.
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Search Alerts/Recalls
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