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 Codes	Peritonitis (2252); Peritoneal effluent abnormal (4904)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this peritoneal dialysis (pd) patient was diagnosed with peritonitis.The patient was seen in the pd clinic on (b)(6) 2026 due to draining issues.During the visit, the patient¿s pd effluent was noted to be cloudy.Pd cultures were obtained.The patient was diagnosed with peritonitis.The patient was initiated on antibiotic therapy with intraperitoneal (ip) vancomycin 1g every 4 days.The cultures were positive for enterococcus faecalis and staphylococcus epidermidis.The cause of the peritonitis is attributed to the patient having an exposed pd catheter cuff.This has been a known issue for several months; however, when the patient came to the clinic on (b)(6) 2026, the exit site was not covered, and the cuff was pulled up.Additionally, the end of the patient¿s pd catheter was inside her underpants between her legs.Prior to the clinic visit, the patient reportedly had diarrhea and abdominal pain for 1 month which she did not report.The pdrn said this patient has a history of social issues in the home and has been known to not have the pd catheter cap on securely.No further information was provided.

• 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: 25162023
• Report Number: 3023981687-2026-00003
• Device Sequence Number: 10729412
• 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): 05/13/2026
• Report Date (Section F): 05/13/2026

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: 05/07/2026
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 05/13/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2026
• 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 Age: 74 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/13/2026