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

Model Number	050-95001
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by a registered nurse (rn) that this patient on peritoneal dialysis (pd) therapy developed peritonitis from a tear in the fresenius stay safe catheter extension set.In a follow-up call with the patient¿s pd nurse, it was reported that on 24/aug/2022 the patient notified the outpatient pd clinic that he experienced a fluid leak from the stay safe catheter extension set due to a visible tear.Later the same day, the patient was seen in the pd clinic and had a pd culture obtained.Per the nurse, the patient¿s pd culture generated growth of the bacteria enterococcus species.The patient was initiated on antibiotic therapy with daily ceftazidime 2 grams intra-peritoneal (ip) on an outpatient basis.The nurse stated it is unknown what caused the tear in the stay safe catheter extension set.It was reported the product was discarded and therefore was not available to return to manufacturer for further product analysis.The nurse attributed the patient¿s peritonitis to a breach in sterile pd pathway due to the reported fluid leak.At the time follow-up was completed, it was indicated the patient is recovering from the peritonitis event.Furthermore, the nurse stated the patient continues pd on the same cycler without further issues.

• Brand Name: STAY SAFE/SAFE 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: 15432195
• Report Number: 3008730267-2022-00145
• Device Sequence Number: 14607915
• Product Code: KDJ
• UDI-Device Identifier: 00840861100767
• UDI-Public: 00840861100767
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/15/2022
• Report Date (Section F): 09/15/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 050-95001
• Device Catalogue Number: 050-95001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/31/2022
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 09/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2022
• 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 Age: 55 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/15/2022