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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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SMITHS MEDICAL ASD, INC. JELCO CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 306701
Device Problems Dull, Blunt (2407); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/09/2019
Event Type  malfunction  
Event Description
Attempt to start 20gx1" iv using smiths medical protective plus catheter, lot #: 3847591, manufacture date: 7/12/2019, felt as if the needle was blunt difficult to penetrate skin unable to advance catheter. Aborted iv attempt and restarted with a new catheter.
 
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Brand NameJELCO
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
MDR Report Key9109075
MDR Text Key159811209
Report Number9109075
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10351688071217
UDI-Public(01)10351688071217
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number306701
Device Lot Number3847591
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/09/2019
Event Location Hospital
Date Report to Manufacturer09/24/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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