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	Abdominal Pain (1685); Peritonitis (2252)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 this male peritoneal dialysis (pd) patient contacted fresenius customer service.The patient stated that he thought he had ordered stay safe caps last year for when he traveled.However, he ended up in the hospital for eleven days with a diagnosis of peritonitis due to no caps.Customer service was unable to substantiate the report of ordering caps.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was traveling when he went to the hospital on (b)(6) 2022 with reports of abdominal pain and cloudy pd effluent.The patient was admitted to the hospital.A pd effluent culture was obtained, and the patient was initiated on antibiotic therapy.The patient was administered intraperitoneal (ip) vancomycin (dose, frequency, and duration unknown).The pd culture resulted in no growth.The patient was discharged on(b)(6) 2022.Upon discharge, the patient¿s antibiotic therapy was adjusted.The vancomycin was discontinued, and the patient was prescribed ip ceftazidime daily for 12 days (dose unknown).The suspected cause of the peritonitis is the patient not having the stay safe cap for the stay safe catheter extension set while traveling.The pdrn stated this is what the patient reported to the clinic; however, the pdrn could not confirm the report as the culture did not return any growth to determine an origin.The patient continued pd therapy utilizing the liberty select cycler during recovery.
Event or Problem Description
On (b)(6) 2023 this male peritoneal dialysis (pd) patient contacted fresenius customer service.The patient stated that he thought he had ordered stay safe caps last year for when he traveled.However, he ended up in the hospital for eleven days with a diagnosis of peritonitis due to no caps.Customer service was unable to substantiate the report of ordering caps.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was traveling when he went to the hospital on (b)(6) 2022 with reports of abdominal pain and cloudy pd effluent.The patient was admitted to the hospital.A pd effluent culture was obtained, and the patient was initiated on antibiotic therapy.The patient was administered intraperitoneal (ip) vancomycin (dose, frequency, and duration unknown).The pd culture resulted in no growth.The patient was discharged on (b)(6) 2022.Upon discharge, the patient¿s antibiotic therapy was adjusted.The vancomycin was discontinued, and the patient was prescribed ip ceftazidime daily for 12 days (dose unknown).The suspected cause of the peritonitis is the patient not having the stay safe cap for the stay safe catheter extension set while traveling.The pdrn stated this is what the patient reported to the clinic; however, the pdrn could not confirm the report as the culture did not return any growth to determine an origin.The patient continued pd therapy utilizing the liberty select cycler during recovery.

• 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: 16242484
• Report Number: 3023981687-2023-00022
• Device Sequence Number: 6606105
• Product Code: KDJ
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 03/01/2023
• Report Date (Section F): 03/01/2023

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 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: 03/01/2023
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 03/01/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 03/01/2023
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/01/2023