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

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Manufacturer Narrative

Investigation on retained representative samples is pending conclusion.

Event Description

5 needle stick injuries reported.No details on how the incident occurred, no date of occurrences, and no product information was documented by the facility, no further information was provided.Our clinical specialist visited the facility on (b)(6) 2017 and watch the staff removing the needles, according to the clinical operations director for the facility, some incidences were due to new employees that were new to dialysis and were using a one hand technique.Our clinical specialist provided an in-service to the clinic for the proper removal the avf needles.1 needle stick to the left thumb.1 needle stick to the left wrist.1 needle stick to the right thumb.1 needle stick to the left finger.1 needle sticl to the left index finger.

• Brand Name: NIPRO AVF TULIP NEEDLE
• 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: 7199799
• MDR Text Key: 191860741
• Report Number: 8041145-2018-00002
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other