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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL PORTEX EPIDURAL CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT
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ST PAUL PORTEX EPIDURAL CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/018CZ
Device Problem Use of Device Problem (1670)
Patient Problem Headache (1880)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative
Only the month (b)(6) and year (b)(6) of the event date are known.(b)(6).The investigation of this complaint was limited because no sample was returned for investigation.Customer complaints similar to this one were previously received.Those complaints were caused by stacked loss of resistance syringes which are used in epidural mini-pack kits.The root cause of the issue was a supplier/manufacturing issue.
 
Event Description
It was reported that an abnormal frequency of dura mater breaches were observed during epidural placement.This presented a risk for post-humeric burst syndrome.The patient experienced headache secondary to epidural analgesia, and a prolongation of their postpartum stay.A blood patch was used to treat the patient.No further complications were reported in relation to this event.
 
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Brand Name
PORTEX EPIDURAL CONTINUOUS TRAYS
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11292668
MDR Text Key230691537
Report Number3012307300-2021-00983
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 foreign,other,user facility
Type of Report Initial
Report Date 02/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number100/391/018CZ
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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