MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO AVF TULIP NEEDLE; AVF NEEDLE

Model Number FT+152530TP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Skin Tears (2516)

Event Date 09/09/2020

Event Type  Injury  

Event Description

Patient care technician pulled the venous needle and when the patient put pressure on the venous access, the arterial needle pierced through the patient's access.According to the clinic, the patient is stable and has no issues.

• Brand Name: NIPRO AVF TULIP NEEDLE
• Type of Device: AVF NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,, 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,, 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 10646369
• MDR Text Key: 210366219
• Report Number: 8041145-2020-00011
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2020

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: Health Professional
• Device Model Number: FT+152530TP
• Device Lot Number: 20D26N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2020
• Initial Date FDA Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2020
• 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): Other