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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL PAIN MANAGEMENT PORTEX EPIDURAL CONTINUOUS TRAYS

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ST PAUL PAIN MANAGEMENT PORTEX EPIDURAL CONTINUOUS TRAYS Back to Search Results
Model Number 18 GUAGE
Device Problem Fluid/Blood Leak (1250)
Patient Problem Pain (1994)
Event Date 07/01/2020
Event Type  malfunction  
Event Description
Information received a smiths medical pain management|portex epidural continuous trays malfunctioned. The user noticed that the device leaked. Issue observed on the whole box. They had to use another device from another lot number. Due to the event the patients pain was not relieved. The leak was noted at the upper end of the catheter tip. No serious patient adverse events was reported.
 
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Brand NamePAIN MANAGEMENT PORTEX EPIDURAL CONTINUOUS TRAYS
Type of DeviceEPIDURAL
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10404172
MDR Text Key202800997
Report Number3012307300-2020-08164
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 user facility
Type of Report Initial
Report Date 08/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number18 GUAGE
Device Catalogue Number100/391/128CZ
Device Lot Number3951235
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2020
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/17/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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