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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
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation completed on a smiths medical pain management|portex kits epifuse connector report of leaking was not confirmed during testing.Physical condition did not reveal any abnormality and when hooking the device to the ti of the connector, this was sealed and water was injected with syringe to increase the pressure but no leakage occurred.In addition, the catheter and flat filter were connected to the connector, and water was injected with a syringe with the catheter closed, but no water leakage was observed.The root cause was not identified.Monitoring will continue and record of event was recorded in database.
 
Event Description
Information received a smiths medical pain management|portex kits other was leaking.The customer reported when applying some force to the syringe to infuse medical fluid into the epifuse connector during the use of it, he noticed medical fluid was leaking from it.No patient injury was reported.
 
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Brand Name
PORTEX
Type of Device
PAIN MANAGEMENT
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11852464
MDR Text Key251651316
Report Number3012307300-2021-04671
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
Report Date 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2021
Was the Report Sent to FDA? No
Date Manufacturer Received04/20/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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