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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON USA; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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VYGON USA; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Device Problems Failure To Adhere Or Bond (1031); Fluid/Blood Leak (1250); Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/28/2016
Event Type  malfunction  
Event Description
Upon checking picc line, rn noticed picc catheter to be slightly pulled out from where it should be, and the tegaderm starting to lift up.Rn at bedside to redress picc dressing.Once the old tegaderm was taken off, the skin appeared wet.Skin cleansed and dried per picc guidelines.New tegaderm placed, however the edges of new tegaderm were not adhering to skin.New tegaderm removed.Skin noted to be wet again.Ivf leaking from picc catheter at the point the wings meet the catheter.Picc removed, catheter intact.No patient harm.Manufacturer response for picc, vygon picc (per site reporter): vygon rep aware and we are waiting for defective product to be picked up/shipping information to be provided.
 
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Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
VYGON USA
2750 morris rd.
suite a200
lansdale PA 19446
MDR Report Key6282523
MDR Text Key65930605
Report Number6282523
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/16/2017
Event Location Hospital
Date Report to Manufacturer01/16/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/27/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Weight4
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