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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 7134-INT
Device Problems Fracture (1260); Physical Resistance/Sticking (4012)
Patient Problem Swelling/ Edema (4577)
Event Date 04/24/2020
Event Type  malfunction  
Event Description
Information was received indicating that the nurse had difficulty introducing a smiths medical peripheral intravenous catheters (pivc)| jelco safety intuitiv catheter. Once in the vein, the nurse felt a resistance by moving up the catheter. When withdrawing the needle, a swelling of the vein was observed. It was also reported that by withdrawing the cathlon, fracture was observed. Edema was observed on the patient. No further adverse effects were reported.
 
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Brand NameJELCO
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
MDR Report Key12474867
MDR Text Key271489304
Report Number3012307300-2021-09369
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 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Catalogue Number7134-INT
Device Lot Number2969698
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
Date Device Manufactured05/20/2015
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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