MAUDE Adverse Event Report: NIPRO THAILAND CORPORATION LTD NIPRO AVF NEEDLE TULIP

Model Number FT+152530TP

Device Problem Device Issue (2379)

Patient Problems Increased Sensitivity (2065); Reaction (2414)

Event Date 01/19/2015

Event Type  Injury  

Event Description

Patient experienced sensitivity to access after using the avf needle, requiring antibiotics and cortisone cream.

Manufacturer Narrative

Device not returned to manufacturer, lot number unknown.Device not returned to manufacturer.

Manufacturer Narrative

Device not returned to manufacturer, lot number unknown, manufacturer investigated reserved samples from different lot numbers, investigation result attached.Device not returned to manufacturer.

Event Description

Patient experienced sensitivity to access after using the avf needle, requiring antibiotics and cortisone cream.

• Brand Name: NIPRO AVF NEEDLE TULIP
• Type of Device: AVF NEEDLE TULIP
• 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: 4906172
• MDR Text Key: 6031922
• Report Number: 8041145-2015-00019
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2015,05/28/2015

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 Model Number: FT+152530TP
• Device Lot Number: UNKNOWN
• 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: 05/11/2015
• Distributor Facility Aware Date: 01/19/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/11/2015
• Date Manufacturer Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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