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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD / SMITHS MEDICAL ASD, INC. 24 G JELCO IV CATHETER RADIOPAQUE; CATHETER, INTRAVASCULAR, THERAPEUTIC SHORT-TERM LESS THAN 30 DAYS
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SMITHS MEDICAL INTERNATIONAL, LTD / SMITHS MEDICAL ASD, INC. 24 G JELCO IV CATHETER RADIOPAQUE; CATHETER, INTRAVASCULAR, THERAPEUTIC SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 1009351
Device Problems Material Puncture/Hole (1504); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/14/2019
Event Type  Injury  
Event Description
Nurse attempted to start piv left foot.Nurse reported, "while pulling back slightly on the needle to advance catheter, nurse felt needle puncture the side of the catheter while the catheter was inserted in the pt." upon nurse removing iv catheter from foot, discovered a portion of the plastic catheter was stuck in pt's foot.Providers called to bedside with unsuccessful attempts to remove.X-ray left foot showed small broken catheter tip along medial aspect of the foot adjacent to base of 1st metatarsal.Plastic surgery consulted (b)(6) 2019.X-ray left foot showed with incision made followed by removal of foreign body / plastic catheter.Nurse reported defective iv catheter.Fda safety report id# (b)(4).
 
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Brand Name
24 G JELCO IV CATHETER RADIOPAQUE
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD / SMITHS MEDICAL ASD, INC.
MDR Report Key9539117
MDR Text Key173503627
Report NumberMW5091965
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1009351
Device Lot Number3831400
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age2 YR
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