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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

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SMITHS MEDICAL INTERNATIONAL, LTD. JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM Back to Search Results
Model Number 4033
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that a smiths medical jelco conventional jelco iv catheters was difficult to insert mechanism, as when sliding into vein the product snaps. It was reported product in the white packages were found to have the malfunction, opposed to the ones in the yellow package. Consequences reported related to incident, were several attempted intravenous pokes to baby, causing delay in the infusion to be prescribed. No adverse patient effects were reported.
 
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Brand NameJELCO
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
1500 eureka park
ashford, kent TN25 4BF
UK TN25 4BF
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL, LTD.
1500 eureka park
ashford, kent TN25 4BF
UK TN25 4BF
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10767649
MDR Text Key214088324
Report Number3012307300-2020-10884
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 11/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4033
Device Catalogue Number4033-AI
Device Lot Number3989941
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/01/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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