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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 Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2019
Event Type  malfunction  
Event Description
Reported by pre op staff that lot #3719639 20 g iv catheter is having issues advancing catheter. The plastic piece you push forward to advanced is extremely difficulty to push forward. Pre op rn reported almost losing this line in pre op because of difficulty. Pre op rns reported this happening several times over the last week.
 
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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 Key8335181
MDR Text Key136043288
Report Number8335181
Device Sequence Number1
Product Code FOZ
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 01/29/2019,02/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number306701
Device Lot Number3719639
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 FDA01/29/2019
Event Location Hospital
Date Report to Manufacturer02/13/2019
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?
Type of Device Usage

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