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

Model Number	050-95004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Peritonitis (2252); Constipation (3274)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted technical support for assistance and during the call the patient reported that they had peritonitis and has been taking medication for constipation and stated that their peritonitis could be the reason for the draining slowly alarms that they have received.Upon follow up, the pdrn stated the patient was seen in the pd clinic on (b)(6) 2023 to have their pd catheter (not a fresenius product) flushed due to not being able to drain.When the patient arrived, the pdrn noted a cloudy pd effluent bag and no cap or pin on the extension set.The missing cap resulted in contamination.A pd effluent culture was obtained.The patient was administered initial one-time doses of antibiotics with intraperitoneal (ip) cefepime 1g and ip vancomycin 1750mg.The culture resulted positive for staphylococcus epidermidis, and the patient¿s white blood cell count was 254.The patient¿s antibiotics were changed.The patient was to continue with ip vancomycin 1750mg for 5 doses.The cause of the patient¿s peritonitis was attributed to contamination from the missing cap and pin on the catheter (not a fresenius product) extension set and to constipation.The extension set was exchanged immediately per policy and procedure.The patient is continuing pd therapy utilizing the liberty select cycler.The pdrn did not confirm if the patient completed treatment on the date of the call to technical support.

• Brand Name: STAY SAFE/LUER 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
• MDR Report Key: 17119858
• Report Number: 3023981687-2023-00117
• Device Sequence Number: 6649634
• Product Code: KDJ
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2023
• Report Date (Section F): 06/13/2023

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 Model Number: 050-95004
• Device Catalogue Number: 050-95004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/26/2023
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 06/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Date Report Sent to FDA: 06/13/2023