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	04/15/2026
Type of Reportable Event	Serious Injury
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.2 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
• MDR Report Key: 25443459
• Report Number: 1056186-2026-00018
• Device Sequence Number: 12216166
• Product Code: FJK
• UDI-Device Identifier: 00383790011884
• UDI-Public: 00383790011884
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/08/2026
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/16/2026
• Device Age: 9 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2026
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/08/2026