Catalog Number ASK-45703-PSJR |
Device Problems
Break (1069); Sticking (1597)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 05/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Patient's current condition is reported as fine.
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Event Description
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The customer reports: triple lumen was attempted in left ij in emergency room.The guidewire was stuck after passing through needle.Needle and wire were removed but piece of wire remained in patient.It was not determined until after the procedure that wire had broken.Access was obtained in another site.Intervention required: surgery to remove the separated swg.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.
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Event Description
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The customer reports: triple lumen was attempted in left ij in emergency room.The guidewire was stuck after passing through needle.Needle and wire were removed but piece of wire remained in patient.It was not determined until after the procedure that wire had broken.Access was obtained in another site.Intervention required: surgery to remove the separated swg.
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Search Alerts/Recalls
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