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

Model Number	FS+173230BC
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer states there was a hole inside of the tubing of a needle.Due to the needle being exposed to blood, it is unavailable for review.Since reporting this complaint, the customer has confirmed that the hole was located directly inside of the tubing, adjacent to the end cap (not the bevel side).The hole penetrated the tubing, causing blood to escape the tubing and drip out.Approximately 200ml of blood leaked.Replacement fluid was administered to the patient with 15 minutes of monitoring the donor.After 15 minutes, donor left the facility feeling well.

• Brand Name: NIPRO AVF SAFETOUCH II NEEDLE
• Common Device Name: AVF NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP., LTD; 10/2 moo 8; bangnomko; sena, ayuthaya 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP., LTD; 10/2 moo 8; bangnomko; sena, ayuthaya 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 25143878
• Report Number: 8041145-2025-00012
• Device Sequence Number: 9779903
• Product Code: FOZ
• UDI-Device Identifier: 00383790000208
• UDI-Public: 00383790000208
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K032777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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
• Operator of Device: Health Professional
• Device Model Number: FS+173230BC
• Device Lot Number: 24J03H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown