Catalog Number ASK-45703-PGM1 |
Device Problem
Material Separation (1562)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165); No Information (3190)
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Event Date 09/05/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).No customer contact information available at the time of this report.Information received via maude report.
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Event Description
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According to the maude report (mdr report key 9109853) "pt presented to ed in diabetic ketoacidosis requiring a central line placed due to poor peripheral vein access, post insertion chest x-ray showed, a piece of retained guidewire.Vascular surgery consulted, pt taken to surgery, with successful removal of wire".There is no customer name or contact information therefore the customer cannot be contacted for additional information.
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Manufacturer Narrative
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Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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According to the maude report (mdr report key 9109853) "pt presented to ed in diabetic ketoacidosis requiring a central line placed due to poor peripheral vein access, post insertion chest x-ray showed, a piece of retained guidewire.Vascular surgery consulted, pt taken to surgery, with successful removal of wire".There is no customer name or contact information therefore the customer cannot be contacted for additional information.
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Search Alerts/Recalls
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