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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. JELCO® PROTECTIV® SAFETY I.V. CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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SMITHS MEDICAL ASD; INC. JELCO® PROTECTIV® SAFETY I.V. CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problems Thrombosis (2100); Foreign Body In Patient (2687)
Event Date 01/13/2020
Event Type  Injury  
Event Description
Information was received indicating that upon removal of a smiths medical jelco® protectiv® safety i.V.Catheter part of catheter was noted to remain in the vessel.The patient was taken to the operating room for successful removal of the catheter and the patient recovered.It was reported that there is a noted deep vein thrombosis (dvt) to the patient's arm.However, it was stated that it is unknown if the dvt occurred prior to iv placement or not.There were no further reported adverse effects.
 
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Brand Name
JELCO® PROTECTIV® SAFETY I.V. CATHETERS
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA,
201 west queen street
southington CT 06489
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key9709051
MDR Text Key179436476
Report Number3012307300-2020-01093
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Date Manufacturer Received01/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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