MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC CYCLER DRAINAGE BAG; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	5C4145NS
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3/d10: the event occurred on an unspecified date in may 2025.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the upper part of two (2)15l cycler drainage bags were cut off.This occurred before use of the devices for peritoneal dialysis therapy.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction made to d4: lot: h25c16050 (previously submitted as h25a17052).Correction made to d4: expiration date: 03/16/2030 (previously submitted as 01/17/2030).Correction made to d4: unique identifier (udi) #: (b)(4).[previously submitted as (b)(4).Correction made to h4: device manufacture date: 03/16/2025 (previously submitted as 01/17/2025).Additional information was added to d9, h3, h6, and h11.H11: two (2) actual devices were received for evaluation.Visual inspection was performed and a damage (cut) to the outlet port, white clamp, and bottom end of pouch was observed.Leak, clear passage and clamp function testing were performed and no issues were observed.The reported condition was verified.The cause of the damage is likely a manufacturing related issue.The defect observed is indicative of a flow wrap pouching equipment damage.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CYCLER DRAINAGE BAG
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; round lake IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 22307155
• Report Number: 2314912-2025-00635
• Device Sequence Number: 8706041
• Product Code: KDJ
• UDI-Device Identifier: 07332414207939
• UDI-Public: (01)07332414207939(10)H25C16050(17)300316
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K214016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: Other
• Device Catalogue Number: 5C4145NS
• Device Lot Number: H25C16050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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