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U.S. Department of Health and Human Services

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

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JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM Back to Search Results
Catalog Number 4030-AI
Device Problems Break (1069); Mechanical Problem (1384)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Information was received indicating that while in use of a smiths medical peripheral intravenous catheters (pivc)|jelco conventional jelco iv catheter, it was noted that some blood had come back, the vein had broken down when the user wanted to move the catheter back into the vein. It was also reported that by removing the catheter, the user realized that the catheter needle had pierced the white plastic catheter. No further adverse effects were reported.
 
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Brand NameJELCO
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
MDR Report Key12470774
MDR Text Key271369862
Report Number3012307300-2021-09360
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
Report Date 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4030-AI
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2021
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 Unkown

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