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	Abdominal Pain (1685); Peritonitis (2252); Peritoneal effluent abnormal (4904)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis registered nurse (pdrn) reported that this patient on continuous ambulatory peritoneal dialysis (capd) had been hospitalized since (b)(6) 2026 due to peritonitis.The patient came into the clinic with no stay safe cap on the pd catheter.Additional information was obtained through follow-up with the pdrn.The patient was seen in the pd clinic on (b)(6) 2026 due to cloudy pd effluent and mild abdominal pain.The patient was noted to have no stay safe cap on the pd catheter.The patient did not know why or how the cap had gone missing.A pd culture was obtained.The patient was diagnosed with peritonitis.The patient went to the emergency room (er) that same day.The patient was admitted to the hospital on (b)(6) 2026.The cultures were positive for klebsiella pneumoniae.The white blood cell count was 116,080 with 93% polymorphonuclear (pmn) cells.The patient was initiated on antibiotic therapy with intraperitoneal (ip) ceftazidime 1.5g daily (for 14 more days).The patient remains hospitalized.The suspected cause of the peritonitis event is the missing stay safe cap.The patient did not require a pd catheter removal.No additional 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: 24086956
• Report Number: 3023981687-2026-00001
• Device Sequence Number: 21276183
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/15/2026
• Report Date (Section F): 01/15/2026

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: 01/13/2026
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 01/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2026
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Date Report Sent to FDA: 01/15/2026