MAUDE Adverse Event Report: NIPRO THAILAND CORPORATION LTD AVF SINGLE NEEDLE; AVF NEEDLE

Model Number SGN1625-HTC-15RBGT

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Hemorrhage/Bleeding (1888); Device Embedded In Tissue or Plaque (3165)

Event Date 04/19/2011

Event Type  Injury  

Event Description

While entering the needle during the puncture of the fistula, there was an inexplicable and abundant blood loss before the needle was placed along the course of the vein.They were unable to stop the blood loss and proceed with the removal of the needle, the needle inexplicably broke inside of the vein.The patient was sent to the emergency room for surgery to remove the needle, prior to radiological monitoring for search of the metal body.

• Brand Name: AVF SINGLE NEEDLE
• Type of Device: AVF NEEDLE
• Manufacturer (Section D): NIPRO THAILAND CORPORATION LTD; 10/2 moo 8, bangnomko, sena; phra nakhon si; ayutthaya 13110, th ; TH
• Manufacturer (Section G): NIPRO THAILAND CORPORATION LTD; 10/2 moo 8, bangnomko, sena; phra nakhon si; ayutthaya 13110, th ; TH
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 4905953
• MDR Text Key: 6830948
• Report Number: 8041145-2015-00013
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K955182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: SGN1625-HTC-15RBGT
• Device Lot Number: 10K02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention