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
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal and possible causal relationship between peritoneal dialysis and utilization of the sterile stay safe cap and the patient event of peritonitis with hospitalization.The cause of the peritonitis was suspected to be the sterile stay safe cap falling off, however; that was not confirmed.The reason for the cap falling off was not known, however; there was no allegation of a defect reported.Additionally, the patient did not report any issues with the cap.The liberty select cycler user¿s guide instructs: check that the new sterile stay¿safe cap is securely attached to your catheter extension set before removing it from the stay¿safe organizer.Klebsiella, the organism which caused the patient¿s peritonitis, is normal flora in the nose, mouth, and intestines.Although no allegation of a defect was reported and no sample was evaluated for this event, the sterile stay safe cap cannot be excluded as causing or contributing to the patient¿s event of peritonitis.
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.
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.
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.There is no product specific ifu for the disinfection cap (050-95012) in place.As no complaint sample was returned and no pictures were attached, an assessment due to deficiency related to falsification was not possible.The complaint sample was not investigated.It was stated in the complaint intake that the complaint sample is not available.An investigation of the retained samples was not carried out.Due to various 100% inspection during manufacturing, it is highly unlikely to detect a failure in the retained samples.Batch record investigation (dhr): based on the missing information about the affected batch, the batch record could not be checked.In general, a batch release is just possible if the products have been inspected according to the inspection protocol and were found conforming to specification.Complaint history review for affected product and product family: in the last 12 months we received further complaints with similar failure descriptions which were related to article 050-95012.A systematic failure at the disinfection cap (manufacturing related) could not be detected.Based on the provided information, the manufacturer determined the cause could not be concluded.
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 patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformanaces 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.
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 (b)(6) 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
• 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: 24086960
• Report Number: 0008030665-2026-00112
• Device Sequence Number: 13207486
• 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: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2026

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
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 04/24/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/04/2026; 04/24/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 68 KG