Model Number 384101 |
Device Problems
Break (1069); Collapse (1099); Difficult to Advance (2920); Mechanical Jam (2983)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Sample is unavailable for evaluation.Videos were provided for analysis.A follow-up will be submitted after videos are analyzed and reviewed.
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Event Description
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On june 8th , a picc catheter was inserted in a child admitted to the pediatric intensive care unit, the catheter was lubricated according to routine, the mandrel was pulled 3cm for introduction, the catheter progressed easily, with good flow and reflux, however, at the moment of total traction of the mandrel, it did not come out, getting stuck to the catheter, collapsed, bringing the catheter out.When forcing the withdrawal, it ended up damaging it.This happened with two catheters in the same patient.Due to the need of access, a third catheter was necessary, in which i removed the mandrel before inserting it, to obtain success in the procedure.I take the opportunity to register that this same episode has already happened in the passage of picc catheter in adults, with me and with my colleagues.
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Event Description
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On (b)(6) , a picc catheter was inserted in a child admitted to the pediatric intensive care unit, the catheter was lubricated according to routine, the mandrel was pulled 3cm for introduction, the catheter progressed easily, with good flow and reflux, however, at the moment of total traction of the mandrel, it did not come out, getting stuck to the catheter, collapsed, bringing the catheter out.When forcing the withdrawal, it ended up damaging it.This happened with two catheters in the same patient.Due to the need of access, a third catheter was necessary, in which i removed the mandrel before inserting it, to obtain success in the procedure.I take the opportunity to register that this same episode has already happened in the passage of picc catheter in adults, with me and with my colleagues.
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Manufacturer Narrative
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A review of the dhr and inspection records was conducted, and no similar concerns were found.There was no sample available for review, however, a video of the reported issue was provided.Based on the review of the video, the resistance was confirmed.Without the sample to review, determining a definite root cause for the resistance is not possible.There have been no other complaints regarding this issue with this lot number.Since a definite root cause could not be established and there have been no other complaints regarding this issue with this lot number, no corrective action will be taken at this time.Argon will continue to monitor for issues of this nature in the future.
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Search Alerts/Recalls
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