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 Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The peritoneal dialysis (pd) patient contacted fresenius technical support during dwell 3 of 6 of treatment on the liberty select cycler to report that a hole was found in their catheter line and request assistance with canceling treatment to go to the emergency room (er).Fresenius technical support assisted the patient with canceling treatment on the cycler.Upon initial follow-up it was reported that the patient is temporarily completing hemodialysis for approximately two weeks.No additional information was known related to the er visit or any medical intervention that could have been provided to the patient.Attempts to obtain additional information were unsuccessful.

• 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: 15670622
• Report Number: 3008730267-2022-00179
• Device Sequence Number: 15068554
• Product Code: KDJ
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/25/2022
• Report Date (Section F): 10/25/2022

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: 09/30/2022
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 10/25/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 10/25/2022