Catalog Number 383572 |
Device Problem
Flushing Problem (1252)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that nexiva 22ga x 1.00 in dp with maxzero had incomplete flush.The following information was provided by the initial reporter: it is reported customer is experiencing leakage.Maxzero ivs that we are using do not allow us to connect and disconnect without having drips of fluid on them.I have tightened them but when we disconnect from the hub, there are still drips of liquid.We are using radioactive material for this.Also the sponge part of the hub, the activity is getting hung up in there.We have to flush it profusely.
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Manufacturer Narrative
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H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.
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Event Description
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It was reported that nexiva 22ga x 1.00 in dp with maxzero had incomplete flush.The following information was provided by the initial reporter: it is reported customer is experiencing leakage.Maxzero ivs that we are using do not allow us to connect and disconnect without having drips of fluid on them.I have tightened them but when we disconnect from the hub, there are still drips of liquid.We are using radioactive material for this.Also the sponge part of the hub, the activity is getting hung up in there.We have to flush it profusely.
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Search Alerts/Recalls
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