MAUDE Adverse Event Report: VYGON USA VALUE LIFE; PICC CATHETER INTRODUCER

Lot Number 1311043

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 09/17/2014

Event Type  malfunction  

Event Description

Peripherally inserted central catheter (picc) inserted with 24 gauge splittable needle.Catheter threaded to 16 cm, when splitting needle, needle did not split all the way and left the nurse (rn) unable to dislodge the catheter.The catheter had to be removed.

• Brand Name: VALUE LIFE
• Type of Device: PICC CATHETER INTRODUCER
• Manufacturer (Section D): VYGON USA; 2750 morris rd., suite a200; lansdale PA 19446
• MDR Report Key: 5013288
• MDR Text Key: 23407013
• Report Number: 5013288
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Report Date: 12/09/2014,07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2016
• Device Lot Number: 1311043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2014
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1