MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STERILE STAY SAFE CAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was diagnosed with peritonitis on (b)(6) 2025.The patient¿s pd registered nurse (pdrn) reported the patient contracted peritonitis due to user error, when she failed to utilize a stay safe end cap after completing treatment.Subsequent attempts to obtain additional clinical information (e.G., causality, discharge summary, hospital records, medication records) were unsuccessful.

• Brand Name: STERILE STAY SAFE CAP
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 22143032
• Report Number: 3023981687-2025-00006
• Device Sequence Number: 8149613
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K083542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/04/2025
• Report Date (Section F): 06/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-95012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/21/2025
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 06/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 06/04/2025