Catalog Number CS-15242-VSP |
Device Problem
Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/31/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer reports that after three months of insertion, for hemodialysis in the hospital, the doctor found the red tube broken and air was in the tube.The device was removed and replaced without issue.
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Manufacturer Narrative
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(b)(4).The customer returned one used j-71524-001 connector assembly for evaluation.Visual inspection was performed and no defects were observed.A lab syringe was used to pass water through both extension lines.No issues were identified.A device history record review was performed and no relevant findings were identified.The customer reported issue of the arterial extension line being separated was not confirmed during sample investigation.Both extension lines were found to be intact during visual and functional inspections.No problem was identified with the returned sample, therefore no additional action shall be taken at this time.
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Event Description
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The customer reports that after three months of insertion, for hemodialysis in the hospital, the doctor found the red tube broken and air was in the tube.The device was removed and replaced without issue.
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Search Alerts/Recalls
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