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

Model Number UNKNOWN

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

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.

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) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,, 13110 ; TH 13110
• MDR Report Key: 10026275
• MDR Text Key: 189922695
• Report Number: 1056186-2015-00010
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• 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: 05/12/2015
• Distributor Facility Aware Date: 04/03/2015
• Date Report to Manufacturer: 05/12/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other