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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 328600
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/03/2020
Event Type  malfunction  
Event Description
Smiths medical asd jelco 20g x 45 mm iv catheter (lot # 3868420) would not thread during the iv insertion on multiple patients.Seven failed sticks due to iv catheter not threading after flash were documented happening on 3 different patients.Four different nurses experienced the same issues when trying to thread the iv catheter.Nurses pulled all catheters within the same lot out of circulation and alerted the unit manager about the recurrent issue.The defective medical devices were returned to the manufacturer on february 7th of 2020.
 
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Brand Name
JELCO
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
MDR Report Key10294793
MDR Text Key199485480
Report Number10294793
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 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number328600
Device Lot Number3868420
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/10/2020
Event Location Hospital
Date Report to Manufacturer07/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age22265 DA
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