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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL PORTEX PAIN MANAGEMENT

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ST PAUL PORTEX PAIN MANAGEMENT Back to Search Results
Catalog Number 24-1301-22
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Information received a smiths medial pain management|portex epidural continuous trays markings no visible. The customer indicated they noticed the marking on the 18g epidural catheter was very faint in comparison to lure kits. On (b)(6) 2021: a form received and the customer responded that the outcome of the event pale markings on catheter make it harder for clinicians to use and less safe.
 
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Brand NamePORTEX
Type of DevicePAIN MANAGEMENT
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key12374222
MDR Text Key268358683
Report Number3012307300-2021-08881
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,user facility
Type of Report Initial,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-1301-22
Device Lot Number4095337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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