Model Number 2420-0500 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that a small hole in the as lvp 20d dehp 2ss cv line caused ns to "spray out".This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "on two separate occasions a new primary iv line was removed from the package and primed with ns.There was a pin point hole in the line that started spraying out.".
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Event Description
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It was reported that a small hole in the as lvp 20d dehp 2ss cv line caused ns to "spray out".This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "on two separate occasions a new primary iv line was removed from the package and primed with ns.There was a pin point hole in the line that started spraying out.".
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Manufacturer Narrative
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Investigation summary: due to no photo or sample being received, the customer's complaint of leakage could not be verified.A device history record review for model: 2420-0500, lot number: 20103006 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06oct2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, the root cause remains unknown.
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Search Alerts/Recalls
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