MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 18 IN.; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Abdominal Pain (1685); Peritonitis (2252)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A voluntary medwatch mw5119435 was received.The report stated that the catheter extension set with luer-lock tip fell off.The patient noticed a leak and as a result was hospitalized.Additional information was provided by follow-up with the peritoneal dialysis registered nurse (pdrn).The patient was seen in the pd clinic on (b)(6) 2023 after the cap on the luer-lock end of the catheter extension set fell off.The patient noted a leak after the cap fell off.The patient was not in active treatment at the time of the cap falling off.While at the clinic, the patient¿s extension set was exchanged for a new one.The extension set was discarded.The patient was administered antibiotics (drug, route, and dose not provided).On (b)(6) 2023 the patient presented to the hospital with complaints of abdominal pain.The patient was admitted with a diagnosis of peritonitis.A pd effluent culture resulted positive for staphylococcus aureus.The patient was prescribed antibiotic therapy with vancomycin (route, dose, frequency, and duration unknown).The patient was discharged on (b)(6) 2023.

• Brand Name: STAY SAFE/LUER LOCK CATHETER EXT. 18 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: 17541919
• Report Number: 3023981687-2023-00164
• Device Sequence Number: 20448171
• Product Code: KDJ
• UDI-Device Identifier: 00840861100798
• UDI-Public: 00840861100798
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/14/2023
• Report Date (Section F): 08/14/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 050-95005
• Device Lot Number: 22SR08086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/26/2023
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 08/14/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2023
• 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; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Date Report Sent to FDA: 08/14/2023