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

Model Number FT+172530TP

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/08/2016

Event Type  Injury  

Manufacturer Narrative

Investigation report attached on retained samples only.Device not returned to manufacturer.

Event Description

Received initial complaint from clinic (b)(6) 2016: the technician was removing the needle from the patient, the needle came through the safety device of the tulip and stuck the technician, technician was sent to the er.Clinical specialist contacted the clinic and spoke with the field administrator (b)(6) 2016, clinic advised that the technician was removing the tulip needle but the technician did not remove all of the tape that was holding the avf needle in place.The technician moved the safety device forward then attempted to remove the last piece of tape, but the tape stuck to the glove.Technician did not notice, pulled the tape off the glove, and the needle stuck the technician.The field administrator confirmed the incident to be a technique issue and not a product malfunction.

• 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, thailand, 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP., LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand, 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 6122786
• MDR Text Key: 60745860
• Report Number: 8041145-2016-00023
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: FT+172530TP
• Device Lot Number: 15F10
• 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: 11/22/2016
• Distributor Facility Aware Date: 11/08/2016
• Device Age: 17 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/22/2016
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2015
• 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): Hospitalization