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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO INTRAVASCULAR CATHETER

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SMITHS MEDICAL ASD, INC. JELCO INTRAVASCULAR CATHETER Back to Search Results
Model Number 306501
Device Problems Fluid Leak (1250); Defective Component (2292)
Patient Problem Insufficient Information (4580)
Event Date 03/26/2021
Event Type  malfunction  
Event Description
During puncture, the catheter insertion procedure requires the safety device to slide in its entirety to retract the needle, requiring the professional to use both hands in this step to retract and disconnect the device. Information was received indicating that when relieving the pressure at the insertion site an making a detachment maneuver with a smiths medical jelco safety protectiv plus peripheral intravenous catheter, there were situations of blood leakage and loss of punctures. There was no reported adverse event.
 
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Brand NameJELCO
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11793004
MDR Text Key249680817
Report Number3012307300-2021-04049
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K990236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial
Report Date 05/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number306501
Device Catalogue Number306501
Device Lot Number3981786
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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