MAUDE Adverse Event Report: PT. NIPRO INDONESIA JAYA NIPRO BLOOD TUBING SET W/TP; BLOODLINE

Model Number	BL+A217/V806-NIJ
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Loss of Vascular Access (4867)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer states that at the end of treatment, upon disconnection of the bloodline, the connection was so tight that a male individual had to apply added pressure to disconnect the blood set from the catheter.The catheter luer broke upon disconnection.3 total incidents.This resulted in hospital admissions for placement of new catheters.No additional information provided.

• Brand Name: NIPRO BLOOD TUBING SET W/TP
• Common Device Name: BLOODLINE
• Manufacturer (Section D): PT. NIPRO INDONESIA JAYA; kawasan industri surya cipta; jl. surya utama no.23 & 24 kav; karawang,, jawa barat 41363 ; ID 41363
• Manufacturer (Section G): PT. NIPRO INDONESIA JAYA; kawasan industri surya cipta; jl. surya utama no.23 & 24 kav; karawang,, jawa barat 41363 ; ID 41363
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 25443666
• Report Number: 3010377171-2026-00002
• Device Sequence Number: 5938806
• Product Code: FJK
• UDI-Device Identifier: 00383790011884
• UDI-Public: 00383790011884
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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
• Device Model Number: BL+A217/V806-NIJ
• Device Lot Number: 25G25L3J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown