MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC LINE ACCESSORIES; SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES

Catalog Number	115959
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the drain port of a prismaflex 5l effluent bag was observed to be broken during use, and the bag was "found wet".There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added h6 and h11: h11: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photo showed the broken bag on the draining port.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the condition was not determined as no further or actual sample testing could be conducted.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: LINE ACCESSORIES
• Common Device Name: SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; round lake IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - MEDOLLA MODENA BLOOD; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 23980367
• Report Number: 9610270-2026-00001
• Device Sequence Number: 16131605
• Product Code: MON
• UDI-Device Identifier: 07332414121594
• UDI-Public: 07332414121594
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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 Catalogue Number: 115959
• Device Lot Number: 2510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• 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
• Patient Sex: Unknown