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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. JELCO OPTIVA I.V. CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

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SMITHS MEDICAL INTERNATIONAL, LTD. JELCO OPTIVA I.V. CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L Back to Search Results
Catalog Number 1022-AI
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Information was received indicating that upon arrival of a package of smiths medical jelco optiva i. V. Catheter, inside was optiva yellow 24g. It was reported that the box was labeled as ordered optiva 22g. There were no reported adverse effects.
 
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Brand NameJELCO OPTIVA I.V. CATHETERS
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
1500 eureka park
ashford, kent TN25 4BF
UK TN25 4BF
Manufacturer (Section G)
NULL
1500 eureka park
ashford, kent TN25 4BF
UK TN25 4BF
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10615555
MDR Text Key209539080
Report Number3012307300-2020-10031
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1022-AI
Device Lot Number3886937
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2019
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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