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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON VYGON; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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VYGON VYGON; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Lot Number 17J041D
Device Problems Leak/Splash (1354); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2019
Event Type  No Answer Provided  
Event Description
Baby requires peripherally inserted central catheter placement for long term intravenous access due to extreme prematurity.Due to baby's size, 1fr catheter with 24g needle was selected.24g needle inserted into r antecubital vein.Good blood flow noted, and catheter inserted into lumen of needle as per protocol.Catheter advancing without difficulty, so catheter held in place while needle was split apart.Needle usually splits apart with little force, but it required more force than usual to split this needle apart.Once needle split apart, it was removed from the field.Catheter then advanced but would not advance past the shoulder.I pulled the catheter back to a peripheral line as it would not advance centrally.I then went to flush the catheter and noted small drops of liquid coming from the middle of the catheter around the 5cm mark.Due to leaking catheter, it was removed from the baby.Baby tolerated procedure well.
 
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Brand Name
VYGON
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
VYGON
2750 morris rd suite a200
lansdale PA 19446
MDR Report Key9586190
MDR Text Key174869809
Report Number9586190
Device Sequence Number1
Product Code DQO
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 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Device Operator No Information
Device Lot Number17J041D
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/23/2019
Event Location Hospital
Date Report to Manufacturer01/14/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/14/2020
Type of Device Usage N
Patient Sequence Number1
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