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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL INTERNATIONAL, LTD. JELCO CONVENTIONAL JELCO IV; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L Back to Search Results
Catalog Number 4033-AI
Device Problem Fluid/Blood Leak (1250)
Patient Problems Burn(s) (1757); Extravasation (1842)
Event Date 01/11/2022
Event Type  Injury  
Event Description
It was reported that children have extravasation injury's.
 
Event Description
It was reported that children have extravasation injury's.
 
Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
 
Event Description
Additional information received.Unsure if the product was at fault.Child need transfer to burns unit.
 
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Brand Name
JELCO CONVENTIONAL JELCO IV
Type of Device
CATHETER, 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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13550267
MDR Text Key285755536
Report Number3012307300-2022-03562
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
4033-AI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4033-AI
Device Lot Number4205143
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age2 MO
Patient Weight5 KG
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