MAUDE Adverse Event Report: VYGON GMBH NUTRLNE TWNFLO; LONG-TERM INTRAVASCULAR CATHETER

Model Number 1252.230

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/03/2018

Event Type  Injury  

Manufacturer Narrative

The device involved in this event will be returned to vggon for evaluation as part of the complaint investigation.The results of this investigation are still pending and will be communicated to fda within 30 days of its conclusion via follow-up mdr.

Event Description

The patient did a tamponade after introduction of the catheter.It was placed a little bit too far, but the reaction of the child was very intense.

• Brand Name: NUTRLNE TWNFLO
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer (Section G): VYGON GMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 7450447
• MDR Text Key: 106155319
• Report Number: 2245270-2018-00016
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K052475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 04/18/2018

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 Model Number: 1252.230
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other