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

Model Number FT+162530TP

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/12/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturer is initiating investigation on retained samples until actual sample is shipped to finalize investigation process.

Event Description

Patient care technician was pulling the venous needle with the right hand and left thumb holding the gauze, had two petals over the needle and under the wing but the needle was not fully engaged/locked and stuck the left thumb.Patient care technician went for blood work and went back to work, no other medical intervention was done.

• Brand Name: NIPRO AVF NEEDLE TULIP
• Type of Device: AVF TULIP 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 ; 5997174234
• MDR Report Key: 4906252
• MDR Text Key: 191851071
• Report Number: 8041145-2015-00031
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2015

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: FT+162530TP
• Device Lot Number: 14L20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other