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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	08/02/2023
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 incurred a leak on (b)(6) 2023 when the connection between the extension set and the patient¿s pd catheter became loose while the patient was sleeping.In additional follow-up with the patient¿s pd nurse, the event was confirmed.The patient had the transfer set replaced in the pd clinic and the old set was discarded (lot # unavailable).Furthermore, it was discovered that on (b)(6) 2023, the patient was noted to have cloudy pd effluent during a routine pd clinic appointment.As a result, the patient had a pd culture obtained which grew streptococcus canis and coagulase negative staphylococcus.The patient was initiated on antibiotic therapy with daily ceftazidime and vancomycin (per clinic protocol) intra-peritoneal (ip) on an outpatient basis.Per the nurse, the patient is recovering from the peritonitis event and continues pd therapy with the same cycler and new transfer set without any further issues.The nurse stated it is unknown what caused the loose connection between the fresenius transfer set and the pd catheter (not a fresenius product).However, the nurse indicated that it was highly suspected it was related to a patient issue.Nonetheless, it was reported that the patient¿s peritonitis was likely attributed to the breach in sterile pd pathway due to the reported fluid leak.
Additional Manufacturer Narrative
Correction: b.2.
Event or Problem Description
It was reported by a registered nurse (rn) that this patient on peritoneal dialysis (pd) therapy incurred a leak on (b)(6) 2023 when the connection between the extension set and the patient¿s pd catheter became loose while the patient was sleeping.In additional follow-up with the patient¿s pd nurse, the event was confirmed.The patient had the transfer set replaced in the pd clinic and the old set was discarded (lot # unavailable).Furthermore, it was discovered that on (b)(6) 2023, the patient was noted to have cloudy pd effluent during a routine pd clinic appointment.As a result, the patient had a pd culture obtained which grew streptococcus canis and coagulase negative staphylococcus.The patient was initiated on antibiotic therapy with daily ceftazidime and vancomycin (per clinic protocol) intra-peritoneal (ip) on an outpatient basis.Per the nurse, the patient is recovering from the peritonitis event and continues pd therapy with the same cycler and new transfer set without any further issues.The nurse stated it is unknown what caused the loose connection between the fresenius transfer set and the pd catheter (not a fresenius product).However, the nurse indicated that it was highly suspected it was related to a patient issue.Nonetheless, it was reported that the patient¿s peritonitis was likely attributed to the breach in sterile pd pathway due to the reported fluid leak.

• 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: 17691011
• Report Number: 3023981687-2023-00197
• Device Sequence Number: 6435251
• Product Code: KDJ
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 11/22/2023
• Report Date (Section F): 11/22/2023

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 Catalogue Number: 050-95004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/22/2023
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 11/22/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 11/22/2023
• 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
• Patient Age: 53 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/22/2023