Model Number 756608025 |
Device Problem
Air/Gas in Device (4062)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Sample is not available for return.Argon is investigating this event and a follow-up report will be submitted after investigation completion.
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Event Description
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The come across a problem with the pleural drain insert, 6 and 8 f, namely when aspiration only air or a large amount of air comes out and any pneumothorax could not be confirmed during the check with ct.There has also been air at the coupling with a three-way valve and the collection bag.So everything that the customer have done before according to our routines.So suspected air intake from the thread opening, customer assume.It has been noted during the last 2 weeks.Very unpleasant.Has anything changed in the make.
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Event Description
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The come across a problem with the pleural drain insert, 6 and 8 f, namely when aspiration only air or a large amount of air comes out and any pneumothorax could not be confirmed during the check with ct.There has also been air at the coupling with a three-way valve and the collection bag.So everything that the customer have done before according to our routines.So suspected air intake from the thread opening, customer assume.It has been noted during the last 2 weeks.Very unpleasant.Has anything changed in the make?.
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Manufacturer Narrative
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A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded.The purple connector that was removed from the kit pinched off the suture sleeve tube when inserted into the female luer thereby keeping and liquid/fluid out of the chamber that the suture string passes through.Without the purple adapter being pushed into the female luer tube and pinching off the suture tube, fluid/liquid is flowing freely into the luer chamber that the string passes through and will always leak out of the hole formed by the string passing through the luer wall.Capa ca-00047 has been issued to determine the cause and appropriate corrective action(s) required, as well as determining the risks associated with this issue.Root cause was identified as design issue and necessary actions are being implemented to address this issue under capa ca-00047.
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Manufacturer Narrative
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Please see updated investigation report: upon further review and lacking a sample for forensic analysis we cannot arrive at a conclusive cause for the air leakage reported by the customer.
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Event Description
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The come across a problem with the pleural drain insert, 6 and 8 f, namely when aspiration only air or a large amount of air comes out and any pneumothorax could not be confirmed during the check with ct.There has also been air at the coupling with a three-way valve and the collection bag.So everything that the customer have done before according to our routines.So suspected air intake from the thread opening, customer assume.It has been noted during the last 2 weeks.
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Search Alerts/Recalls
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