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

Model Number	FD+152530BCR-CAP
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Received email notification from the fda with medwatch report number mw5175663, per 803.22 (b)(2).Details below: it was reported via email that a patient discovered a hole in tubing of needle hub.Resulted in approx.100cc blood loss and discontinuation of treatment.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
Event or Problem Description
Received email notification from the fda with medwatch report number mw5175663 attached, per 803.22 (b)(2).Details below: it was reported via email that a patient discovered a hole in tubing of needle hub.Resulted in approximately 100 cc blood loss and discontinuation of treatment.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NIPRO AVF BIOHOLE 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: 23410221
• Report Number: 8041145-2025-00010
• Device Sequence Number: 10268908
• Product Code: FIE
• UDI-Device Identifier: 00383790001250
• UDI-Public: 00383790001250
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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
• Operator of Device: Health Professional
• Device Model Number: FD+152530BCR-CAP
• Device Lot Number: 23J24A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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: Other
• Patient Sex: Unknown