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

Model Number UNKNOWN

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer, product code and lot not recorded, evaluation on random sample pending.

Event Description

While the dialysis technician tried to engage the safety device, the needle went through the side and stuck the technician in the hand.No further information was provided.No product code or lot information recorded.

• Brand Name: NIPRO AVF NEEDLE
• 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: 10026578
• MDR Text Key: 191029421
• Report Number: 1056186-2015-00014
• Device Sequence Number: 1
• Product Code: FIE
• 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
• 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: 01/30/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/12/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date 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