Catalog Number 2426-0500 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device expiration date: unknown.Initial reporter facility name: uw health ¿ university hospital and american family children¿s hospital.Device manufacture date: unknown.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 the gem v/nv 20dp ckv 2ss 117-in 20pk experienced leakage.The following information was provided by the initial reporter: complaint 1 of 2 material #: 2426-0500.Lot#: unknown.Tubing started leaking at a connection by a port during an infusion.Rn alerted by parent of a patient receiving an infusion.
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Event Description
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It was reported that the gem v/nv 20dp ckv 2ss 117-in 20pk experienced leakage.The following information was provided by the initial reporter: complaint 1 of 2.Material #: 2426-0500 lot#: unknown.Tubing started leaking at a connection by a port during an infusion.Rn alerted by parent of a patient receiving an infusion.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-12-17.Investigation summary : one sample was received for quality investigation.The customer complaint of the tubing leaking at a connection by a port could not be verified by inspection.Visual inspection of the infusion set did not reveal any visible cuts or pinhole in the tubing, and there were not cracks in the components, however, the lower luer lock fitting was missing from the infusion set.A simulated infusion was then conducted to determine if any leakage can be observed.There was no signs of leakage throughout the entire infusion set.A device history record review could not be performed on model 2426-0500 because a lot number was not provided by the customer.A root cause was not established because the failure mode could not be replicated.
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Search Alerts/Recalls
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