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	Serious Injury
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
• MDR Report Key: 25143164
• Report Number: 1056186-2025-00041
• Device Sequence Number: 9779885
• Product Code: FOZ
• UDI-Device Identifier: 00383790000208
• UDI-Public: 00383790000208
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/14/2025
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 05/11/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/11/2026