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.
Additional Manufacturer Narrative
Clinical review: there is a temporal and possible causal relationship between pd therapy utilizing the stay safe cap and the patient event of peritonitis.However, there is no documentation of a defect or malfunction of the stay safe cap.The patient did not report any issue with the cap or state that the cap fell off.It is unknown why the patient did not have a cap on.It is unknown if the patient did not place a cap on or if it fell off.The liberty select cycler user¿s guide instructs: carefully disconnect the patient line from your extension set and cap off with a new sterile stay¿safe cap.The pd effluent culture was not available and therefore the etiology of the peritonitis could not be determined.Based on the available information, the stay safe cap cannot be excluded as the cause of the patient¿s peritonitis event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
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.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the customer for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combiset bloodlines shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Additional Manufacturer Narrative
Correction: g3 (date received).The date received on the initial submission for this report is incorrectly indicated as 11/6/2025.The correct date is 11/11/2025.
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.
Additional Manufacturer Narrative
Plant investigation: no parts or samples were returned to the manufacturer which prevented the completion of a physical evaluation.Additionally, a lot number was not included among the information provided by the customer which prevented the review of any retained samples.The manufacturer confirmed that the batch release occurs when all products have been inspected according to protocol and found to be conforming to specification.Based on the provide information, the manufacturer determined the cause for the reported issue to be a user-related issue since the patient arrived at the hospital without a stay safe cap connected to the catheter.
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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 20725590
• Report Number: 0008030665-2024-01092
• Device Sequence Number: 8976979
• 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: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/15/2025

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
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 01/17/2025; 05/14/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/18/2024; 01/21/2025; 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female