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 Problem 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
• MDR Report Key: 10646234
• MDR Text Key: 210374512
• Report Number: 1056186-2020-00010
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2020
• Distributor Facility Aware Date: 09/15/2020
• Device Age: 5 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other