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	11/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis registered nurse [(pd)rn] reported that this pd patient was hospitalized for peritonitis.The patient reportedly arrived at the clinic without a stay-safe cap on the pd catheter (not a fresenius product).Additional information was obtained through follow-up with the pdrn.The patient was seen in the clinic in (b)(6) 2024 due to issues with the pd catheter.When the patient arrived, there was no stay-safe cap on the pd catheter.The patient¿s transfer set was changed per the md instructions.The patient was sent to the hospital from the clinic.The patient was admitted to the hospital on (b)(6) 2024 for a non-functioning pd catheter and peritonitis.The pdrn did not have any culture results or antibiotic information available.The patient¿s antibiotics were administered in the hospital.During the hospitalization, the patient¿s pd catheter was removed, and the patient was transitioned to hemodialysis (hd).The patient was discharged on (b)(6) 2024.The patient is completing back-up hd until december when the patient will receive a new pd catheter and return to pd.The cause of the peritonitis has been attributed to not having the stay safe cap on the pd catheter.No additional information pertaining to the peritonitis event was available.

• 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: 20737057
• Report Number: 3023981687-2024-00255
• Device Sequence Number: 12856289
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/20/2024
• Report Date (Section F): 11/20/2024

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: Health Professional
• 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: 11/11/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 11/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2024
• 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; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/20/2024