• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PAIN MANAGEMENT PORTEX EPIDURAL CONTINUOUS TRAYS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. PAIN MANAGEMENT PORTEX EPIDURAL CONTINUOUS TRAYS Back to Search Results
Catalog Number A4134-17
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Undesired Nerve Stimulation (1980)
Event Date 03/01/2020
Event Type  Injury  
Event Description
Information received a smith medical pain management|portex epidural continuous trays caused catheter to break on a women in labor receiving pain relief. Anesthesiology attempted to place a l4 and l5 epidural on one attempt there was a loss of resistance when the catheter was thread. The anesthesiology felt some resistance so they stopped. The patient reported a transient right side parenthesia so they decided to pull the catheter and reposition. The catheter was at 12cm at the touhy needle hub. When the anesthesiology pull the catheter they felt a sudden snap. The catheter was reported to break off inside the patient. The needle skin was inspected and the coiled wire was still in the patient, it was pulled and removed. When the catheter was inspected by provider, it was found broken at appx 4cm. More information revealed the women had an mri after incident and neurosurgery was consulted and told patient no further intervention and to follow up with outpatient care. June was last visit patient was seen and no adverse event reported at that time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePAIN MANAGEMENT PORTEX EPIDURAL CONTINUOUS TRAYS
Type of DeviceEPIDURAL
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
MDR Report Key10268420
MDR Text Key198681114
Report Number3012307300-2020-07239
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2021
Device Catalogue NumberA4134-17
Device Lot Number3922278
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/13/2020 Patient Sequence Number: 1
-
-