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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERVENOUS CATHETERS JELCO

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INTERVENOUS CATHETERS JELCO Back to Search Results
Catalog Number 7218-AI
Device Problem Material Disintegration (1177)
Patient Problem Hematoma (1884)
Event Date 07/20/2021
Event Type  Injury  
Event Description
Information received a smiths medical peripheral intravenous catheters (pivc)|jelco safety intuitive catheters interrupted procedure. Reported once the device was in place, there was initially a lot of pressure to get the injectable medication into the catheter. After a few moments, the pressure of resistance stopped and at the end of the administration when the syringe was withdrawn, the blood flow from the vein is observed causing an hemorrhage. This becomes a withdrawal emergency.
 
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Brand NameINTERVENOUS CATHETERS
Type of DeviceJELCO
MDR Report Key12351895
MDR Text Key267619658
Report Number3012307300-2021-08679
Device Sequence Number1
Product Code FOZ
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 09/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7218-AI
Device Lot Number3932637
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/12/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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