Catalog Number 393224 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device lot #: the customer provided lot # 0229500p02.This does not match the catalog number provided.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 venflon pro safety 20ga 1.1mm od 32mm l hub separated.The following information was provided by the initial reporter: during the insertion of the cvp, after punching the vein, the metallic spindle of the cvp retracted itself.The retraction of the mandrel has carried the cannula with it as if the mandrel were not detached from the cannula.At the time of the spindle removal part of the cannula broke remaining in the forearm of the patient, part that was removed with surgical forceps.
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Manufacturer Narrative
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Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
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Event Description
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It was reported that venflon pro safety 20ga 1.1mm od 32mm l hub separated.The following information was provided by the initial reporter: during the insertion of the cvp, after punching the vein, the metallic spindle of the cvp retracted itself.The retraction of the mandrel has carried the cannula with it as if the mandrel were not detached from the cannula.At the time of the spindle removal part of the cannula breaked remaining in the forearm of the patient, part that was removed with surgical forceps.
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Search Alerts/Recalls
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