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

Model Number FS+173230BC

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2023

Event Type  malfunction  

Event Description

Needle did not retract into sheath (safety mechanism).

• Brand Name: NIPRO SAFETOUCH II 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: 16456480
• MDR Text Key: 310407535
• Report Number: 1056186-2023-00003
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS+173230BC
• Device Catalogue Number: FS+173230BC
• Device Lot Number: 22H12J
• 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: 02/28/2023
• Distributor Facility Aware Date: 02/15/2023
• Device Age: 6 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other