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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
Catalog Number 4030-AI
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 01/12/2020
Event Type  Injury  
Event Description
Information was received indicating that upon the removal of a smiths medical peripheral intravenous catheters (pivc)|jelco conventional jelco iv catheter, the top plastic tip broke off into the patient's vein. No further adverse 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
MDR Report Key12469435
MDR Text Key271334880
Report Number3012307300-2021-09352
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 distributor
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 Number3670861
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 Manufactured07/26/2018
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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