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

Model Number	FS+173230BC
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Samples have been requested.Pending customer's response on sample availability in order to finalize the investigation.Initial investigation report attached is on retained samples only.
Event or Problem Description
Customer reporting leakage of blood from the connection point between the hard plastic and the tubing.There was approximately 200ml of blood loss.No additional information was provided.
Additional Manufacturer Narrative
Samples have been requested.Pending customer's response on sample availability in order to finalize the investigation.Initial investigation report attached is on retained samples only.On 5/62026, customer never returned samples.Finalized report attached is on retained samples only.
Event or Problem Description
Customer reporting leakage of blood from the connection point between the hard plastic and the tubing.There was approximately 200 ml of blood loss.No additional information was provided.

• Brand Name: NIPRO SAFETOUCH II AVF 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: 22144968
• Report Number: 8041145-2025-00006
• Device Sequence Number: 12870958
• 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: Company Representative,Distributor
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FS+173230BC
• Device Lot Number: 24E21B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2024
• 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: Other
• Patient Sex: Unknown