Catalog Number BP-05501 |
Device Problem
Material Rupture (1546)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 02/13/2024 |
Event Type
Injury
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Event Description
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It was reported that "while attempting to remove epidural catheter, the catheter broke.It was determined that surgery is needed to remove the flextip plus catheter due to a concern the catheter might migrate if left in patient.Surgery scheduled for week of (b)(6) 2024.Patient as i know it is fine, but still need surgery to remove the catheter and that has not happened yet".At the time of this report, the customer has not returned our requests for additional information.
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Manufacturer Narrative
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Qn# (b)(4).
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Manufacturer Narrative
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Qn# (b)(4).Additional information received indicates "patient required laminectomy to remove retained catheter".It was also reported that the patient did not experience any signs or symptoms due to this event, and the condition of the patient was "stable".The actual device was not returned; however, the customer did provide a photo that appears to show a separated catheter.A device history record review was performed on the epidural catheter with no relevant findings.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter with no relevant findings.The customer did provide a photo that appears to show a separated catheter; however, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.Other remarks: n/a, corrected data: n/a.
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Event Description
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It was reported that "while attempting to remove epidural catheter, the catheter broke.It was determined that surgery is needed to remove the flextip plus catheter due to a concern the catheter might migrate if left in patient.Surgery scheduled for week of (b)(6) 2024.Patient as i know it is fine, but still need surgery to remove the catheter and that has not happened yet".
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Search Alerts/Recalls
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