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

Model Number UNKNOWN

Device Problems Retraction Problem (1536); Fail-Safe Problem (2936)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Manufacturer Narrative

No product code, no lot information recorded.

Event Description

While dialysis technician was attempting to engage the safety device, the needle went through the side and punctured the technician.Date of incident unknown, no further information was provided.

Manufacturer Narrative

No product code, no lot information recorded.** correct importer report number is (b)(4).** device problem code added, manufacturer investigated reserved samples from different lot numbers.Device not returned to manufacturer.

Event Description

While dialysis technician was attempting to engage the safety device, the needle went through the side and punctured the technician.Date of incident unknown, no further information was provided.

Manufacturer Narrative

No product code, no lot information recorded.

Event Description

While dialysis technician was attempting to engage the safety device, the needle went through the side and punctured the technician.Date of incident unknown, no further information was provided.

• Brand Name: NIPRO AVF NEEDLE TULIP
• Type of Device: AVF NEEDLE
• Manufacturer (Section D): NIPRO THAILAND CORPORATION LTD; 10/2 moo 8, bangnomko, sena; phra nakhon si; ayutthaya 13110, th 13110 ; TH 13110
• MDR Report Key: 4906212
• MDR Text Key: 189912946
• Report Number: 8041145-2015-00020
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K071145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2015,05/28/2015

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2015
• Distributor Facility Aware Date: 04/03/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/12/2015
• Date Manufacturer Received: 05/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other