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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX; 21G PORTEX EPIFUSE EPIDURAL CATH
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SMITHS MEDICAL PORTEX; 21G PORTEX EPIFUSE EPIDURAL CATH Back to Search Results
Device Problems Break (1069); Difficult to Insert (1316); Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/14/2015
Event Type  malfunction  
Event Description
A (b)(6) presents to l&d in active labor.Anesthesiologist presents to bedside for epidural placement.Patient is positioned to side of bed for procedure.After discussion of intended procedure and assessment anesthesiologist proceeds to place epidural.Three attempts were made to place epidural catheter.On one attempt epidural catheter was noted to have sheared approximately 1/2 - 3/4 cm and possibly retained.Anesthesia provider states that needle and catheter were removed simultaneously as according to recommendations.Epidural catheter was successfully placed on third attempt and patient received complete pain relief.Mri was performed on postpartum day 1.During the course of her stay she exhibited no unusual pain or difficulty in ambulation.Patient was routinely discharged home on postpartum day two.
 
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Brand Name
PORTEX
Type of Device
21G PORTEX EPIFUSE EPIDURAL CATH
Manufacturer (Section D)
SMITHS MEDICAL
keene NH 03431
MDR Report Key5187411
MDR Text Key29980923
Report NumberMW5057495
Device Sequence Number1
Product Code BSO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Other Device ID Number(01)00351688054961
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age20 YR
Patient Weight78
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