Model Number 384539 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 08/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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It is unknown if sample will get returned for evaluation or not.There were no images or videos provided for investigation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided or sample is returned in the future, a follow-up report will be submitted.It is unknown if sample will get returned for evaluation or not.
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Event Description
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¿line rn placing new picc line.During insertion, picc line broke off in pts arm.Stat cxr and us obtained.Attending and general surgery to bedside.¿.
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Event Description
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¿line rn placing new picc line.During insertion, picc line broke off in pts arm.Stat cxr and us obtained.Attending and general surgery to bedside.¿.
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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.One opened catheter was returned for review.Visual inspection confirmed breakage of the catheter at the base of the luer.The breakage site was examined under magnification and jagged remnants of the catheter were inside the luer.The luer also exhibited a hair line crack.The most probable cause for the breakage was most likely due to an event within the user environment.Possibly a tensile force was applied to the catheter that resulted in the breaking away of the catheter tubing from the luer.There have been no other complaints regarding this issue with this lot number.Since the reported issue was most likely related to an event within the user environment, 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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