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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

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ST PAUL JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L Back to Search Results
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the wings of the jelco safety viavalve catheter were digging into patient's skin. The operator also indicated that it was hard to thread. The user was also unable to see blood return/or flashback. The product problem did not cause or contribute to any patient injury.
 
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Brand NameJELCO
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11663850
MDR Text Key245339644
Report Number3012307300-2021-03101
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 04/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/16/2021
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? No
Type of Device Usage

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