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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL PIVC JELCO VIA VALVE

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ST PAUL PIVC JELCO VIA VALVE Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/16/2021
Event Type  Injury  
Event Description
Information received a smiths medical peripheral intravenous catheters (pivc)|jelco safety viavalve catheters upon removal of 20g iv from patients left antecubital vein, the cannula appeared much shorter than normal and after consultation with nurse educator it appeared to be not intact. Medical staff that confirmed portion of iv catheter was stuck in patient after removal and not retrievable.
 
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Brand NamePIVC JELCO
Type of DeviceVIA VALVE
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 Key12063600
MDR Text Key258289302
Report Number3012307300-2021-06515
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 06/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2021
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/31/2021
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 Initial

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