MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/SAFE LOCK CATHETER EXT. 12 IN.; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
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 stay safe/luer lock catheter extension set for renal replacement therapy (rrt) will be getting her pd catheter (not a fresenius product) removed due to contracting peritonitis.Follow-up documentation from the patients¿ pd registered nurse (pdrn) revealed the patient presented to the outpatient home dialysis clinic after her pd catheter (not a fresenius product) disconnected from the transfer set (no visible damage noted).A peritoneal effluent fluid culture and cell count (wbc = 122 mm3, polymorphs = 73%) were collected, and the patient was sent home.The patient¿s peritoneal effluent culture result returned positive for enterococcus faecalis, stenotrophomonas maltophilia, and comamonas testosteroni on (b)(6) 2025, and the patient was treated with a single intraperitoneal (ip) dose of gentamycin 80 mg.The pdrn attributed causality to the patient swimming in a pool on multiple occasions which could have contributed to the disconnection of the transfer set (sample unavailable) from the pd catheter.As a result, the patient¿s pd catheter was scheduled to be removed as an outpatient on (b)(6) 2025, and the patient will transition to incenter hemodialysis (hd) for rrt.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review: it is unknown if a temporal relationship exists between ccpd therapy utilizing a stay safe/luer lock catheter extension set and the serious adverse events of peritonitis, which warranted antibiotic therapy, pd catheter (not a fresenius product) removal, and the patient¿s transition to hd for rrt (access type not provided.The pdrn attributed causality to the patient swimming in a pool on multiple occasions, which could have also contributed to the disconnection of the transfer set (sample unavailable) from the pd catheter.Enterococcus faecalis is a normal inhabitant of the human gastrointestinal tract, and peritoneal enterococcal infections are usually the result of a touch contamination event or from a gastrointestinal source.Stenotrophomonas maltophilia bacteria are inhabitants of soil, water and from a variety of foods.Comamonas¿testosteroni are gram-negative bacteria commonly found in soil, water reservoirs, and plants.Based on the information available, the patient¿s stay safe/luer lock catheter extension set can be disassociated from the serious adverse events.There was no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there was no report of a fresenius device(s) and/or product(s) failing to meet the users¿ expectations and/or the manufacturers¿ specifications.
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 stay safe/luer lock catheter extension set for renal replacement therapy (rrt) will be getting her pd catheter (not a fresenius product) removed due to contracting peritonitis.Follow-up documentation from the patients¿ pd registered nurse (pdrn) revealed the patient presented to the outpatient home dialysis clinic after her pd catheter (not a fresenius product) disconnected from the transfer set (no visible damage noted).A peritoneal effluent fluid culture and cell count (wbc = 122 mm3, polymorphs = 73%) were collected, and the patient was sent home.The patient¿s peritoneal effluent culture result returned positive for enterococcus faecalis, stenotrophomonas maltophilia, and comamonas testosteroni on (b)(6) 2025, and the patient was treated with a single intraperitoneal (ip) dose of gentamycin 80 mg.The pdrn attributed causality to the patient swimming in a pool on multiple occasions which could have contributed to the disconnection of the transfer set (sample unavailable) from the pd catheter.As a result, the patient¿s pd catheter was scheduled to be removed as an outpatient on (b)(6) 2025, and the patient will transition to incenter hemodialysis (hd) for rrt.
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 liberty cycler sets 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.There is no allegation of cassette 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 cassette malfunction.As there is no allegation related to product manufacture, the complaint is deemed unconfirmed.

• Brand Name: STAY SAFE/SAFE LOCK CATHETER EXT. 12 IN.
• 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: 22322979
• Report Number: 0008030665-2025-01439
• Device Sequence Number: 21069718
• Product Code: KDJ
• UDI-Device Identifier: 00840861100767
• UDI-Public: 00840861100767
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 050-95001
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/21/2025
• 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; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 99 KG