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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
Catalog Number 308600
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction, Injection Site (2442)
Event Date 06/27/2017
Event Type  Injury  
Event Description
It was reported that a jelco® protectiv® safety i.V.Catheter has been set on the (b)(6) 2017 on a patient by a nurse.On the morning of the (b)(6) 2017, a lymphangitis appeared in patient's arm before the coronography test.
 
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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 north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
201 west queen street
southington CT 06489
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key7511358
MDR Text Key108164444
Report Number3012307300-2018-10295
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10351688071316
UDI-Public10351688071316
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
Type of Report Initial
Report Date 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number308600
Device Lot Number3319353
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/03/2017
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 N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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