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

Catalog Number	050-95004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient was diagnosed with peritonitis.The patient contact confirmed that the patient has been administered antibiotics through a 6-hour dwell in addition to the regularly scheduled pd treatments.Upon follow up, the patient¿s pd nurse stated that the patient was seen in the outpatient pd clinic (on 26/apr/2024) after the patient cut the cap of the transfer set off with scissors.The patient had a pd culture obtained (the same day) which grew the bacteria staphylococcus epidermis, and the patient was diagnosed with peritonitis.The patient was initiated on intra-peritoneal (ip) vancomycin and ceftazidime (per clinic protocol).The nurse indicated that the patient¿s family is currently performing pd treatment for the patient with the same cycler.The patient is recovering from the event.The pd nurse confirmed the patient did not have any fluid leaks or issues with fresenius products in relation to the peritonitis.The nurse reported that the patient been declining in her mental status.In addition to the patient cutting the transfer set with scissors, the patient was not performing aseptic technique with her pd treatments.As a result, the nurse stated the patient will be moving to hemodialysis as she is no longer a good candidate for pd therapy.

• 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: 19315819
• Report Number: 3023981687-2024-00130
• Device Sequence Number: 15204571
• Product Code: KDJ
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• Combination Product (Y/N): N
• 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): 05/14/2024
• Report Date (Section F): 05/14/2024

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: 050-95004
• Device Lot Number: 23NR08103
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/03/2024
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 05/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• Date Device Manufactured: 10/03/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Date Report Sent to FDA: 05/14/2024