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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL INTERNATIONAL, LTD. JELCO PIVC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L Back to Search Results
Catalog Number 4033-AI
Device Problem Material Fragmentation (1261)
Patient Problem Insufficient Information (4580)
Event Date 10/13/2023
Event Type  Injury  
Manufacturer Narrative
Other, other text: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported that following the attempt to establish a peripheral venous line on the right foot of a premature baby in neonatology, a piece of cathlon (foreign body of approximately 1.5cm) remained stuck under the skin after cracking during removal.The reported problem occurred during use on the patient.The operator of the device was a nurse.The incident caused clinical consequences for the patient.The customer indicated that there were associated examinations, and intervention to remove the foreign body was carried out by an orthopedic surgeon.The incident was resolved.
 
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Brand Name
JELCO PIVC
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
Manufacturer Contact
jim vegel
MDR Report Key18107141
MDR Text Key327865030
Report Number3012307300-2023-10425
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K990236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number4033-AI
Device Lot Number4392854
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/23/2023
Initial Date FDA Received11/09/2023
Supplement Dates Manufacturer Received01/25/2024
Supplement Dates FDA Received02/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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