MAUDE Adverse Event Report: VYGON CORP PREMICATH; CATHETER

Model Number 1261.203G

Device Problems Bent (1059); Defective Component (2292); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 12/24/2013

Event Type  malfunction  

Event Description

The physician used the premicath catheter to attempt peripherally inserted central catheter (picc) placement in left foot.While she placed the 24g splitting needle in, she advanced per guidelines and snapped off wings per usual procedure.However at this time, the needle was unable to be advanced.The attending physician was called in to assist with advancement and after attempts, line was taken out and catheter noted to be bent at "wrong place".

• Brand Name: PREMICATH
• Type of Device: CATHETER
• Manufacturer (Section D): VYGON CORP; 2750 morris rd suite a200; lansdale PA 19446
• MDR Report Key: 3549758
• MDR Text Key: 18363002
• Report Number: 3549758
• Device Sequence Number: 1
• Product Code: MSD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1261.203G
• Device Catalogue Number: 1261.203G
• Device Lot Number: 050313GB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2014
• Patient Sequence Number: 1
• Patient Age: 7 DAY