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
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review: a temporal relationship exists between ccpd therapy utilizing the stay safe end cap and the serious adverse event of peritonitis.The patient¿s pdrn attributed causality to the patient failing to apply a stay safe end cap on the pd catheter (not a fresenius product) following the completion of treatment.It should be noted that limited clinical follow-up information precluded a more comprehensive clinical investigation.Those individuals undergoing pd for rrt (manual or cycler based) are at high risk for infections of the peritoneum.Based on the information available, the patient¿s stay safe end cap can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there is no report that a fresenius device(s) and/or product(s) failed to meet the users¿ expectations and/or the manufacturers¿ specifications, as the patient continues to utilize the same liberty select cycler without reported issue.
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.
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
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.
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.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.There is no allegation of malfunction based in the complaint description and information provided, the reported peritonitis was attributed to a breach in aseptic technique.There is no allegation of malfunction.As there is no allegation related to product manufacture, the complaint is deemed as unconfirmed.

• 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: 22143033
• Report Number: 0008030665-2025-01262
• Device Sequence Number: 8149614
• 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: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2025

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: 05/21/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 07/04/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/16/2025; 07/07/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female