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

Catalog Number	050-95001
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Abdominal Pain (1685); Peritonitis (2252)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 24/jan/2024, a nx-stage area manager reported to post market surveillance that there was an allegation of a possible product deficiency involving the fresenius stay safe/safe lock catheter extension (product number 050-95001) in the (b)(6) clinic.The area manager provided the nurse contact email and additional follow-up was performed.On 25/jan/2024, the nurse contact reported that the (b)(6) clinic had a few patients that experienced a crack in the fresenius stay safe/safe lock catheter extension set (where the red end meets the copak) and as a result some of the patient¿s developed peritonitis.In an additional follow-up call to the nurse contact, it was reported that there were five peritoneal dialysis (pd)patients who developed peritonitis in association with the cracked pd catheter extension sets.The five peritonitis events occurred over time with the first event occurring on (b)(6) 2023 and the last reported event on (b)(6) 2024.Per clinic protocol, during a pd clinic visit each patient has the fresenius stay safe/safe lock catheter extension changed.Per the nurse, each crack in the extension set was discovered when the patient came into the pd clinic.Per the nurse, all the actual samples of the product involved in each instance of peritonitis have been discarded.Additionally, the nurse was not able to provide the lot#/#¿s for the involved products.There were no other allegations of additional adverse events related to the cracked extension sets.This clinic investigation was performed the capture the nature of the peritonitis event for this male patient with the initials (b)(6) per the nurse, the patient had the pd catheter extension set placed on (b)(6) 2023 (lot # unknown).On (b)(6) 2023, this patient was seen in the outpatient pd clinic for abdominal pain and cloudy effluent.The patient had a pd culture obtained (the same day) which grew corynebacterium species.The patient was initiated on a 3-week course of antibiotic therapy using vancomycin and fortaz (per clinic protocol) on an outpatient basis.During the pd clinic visit, a crack in the pd catheter extension set was discovered and peritonitis was attributed to the product.The patient had the pd catheter extension set changed and the patient continued pd therapy with the same cycler.The nurse confirmed the patient recovered from the peritonitis event.
Event or Problem Description
On (b)(6) 2024, a nx-stage area manager reported to post market surveillance that there was an allegation of a possible product deficiency involving the fresenius stay safe/safe lock catheter extension (product number 050-95001) in the (b)(6) clinic.The area manager provided the nurse contact email and additional follow-up was performed.On (b)(6) 2024, the nurse contact reported that the (b)(6) clinic had a few patients that experienced a crack in the fresenius stay safe/safe lock catheter extension set (where the red end meets the copak) and as a result some of the patient¿s developed peritonitis.In an additional follow-up call to the nurse contact, it was reported that there were five peritoneal dialysis (pd)patients who developed peritonitis in association with the cracked pd catheter extension sets.The five peritonitis events occurred over time with the first event occurring on 2/feb/2023 and the last reported event on 4/jan/2024.Per clinic protocol, during a pd clinic visit each patient has the fresenius stay safe/safe lock catheter extension changed.Per the nurse, each crack in the extension set was discovered when the patient came into the pd clinic.Per the nurse, all the actual samples of the product involved in each instance of peritonitis have been discarded.Additionally, the nurse was not able to provide the lot's for the involved products.There were no other allegations of additional adverse events related to the cracked extension sets.This clinic investigation was performed the capture the nature of the peritonitis event for this male patient with the initials (b)(6) per the nurse, the patient had the pd catheter extension set placed on (b)(6) 2023 (lot # unknown).On (b)(6) 2023, this patient was seen in the outpatient pd clinic for abdominal pain and cloudy effluent.The patient had a pd culture obtained (the same day) which grew corynebacterium species.The patient was initiated on a 3-week course of antibiotic therapy using vancomycin and fortaz (per clinic protocol) on an outpatient basis.During the pd clinic visit, a crack in the pd catheter extension set was discovered and peritonitis was attributed to the product.The patient had the pd catheter extension set changed and the patient continued pd therapy with the same cycler.The nurse confirmed the patient recovered from the peritonitis event.Additional follow up was conducted per manufacturing request to inquire the associated clinic¿s method (as well as chemical used) for cleaning the stay safe extension set while in use.The pdrn indicated that the blue end of the stay safe extension set (the port which connects to the fresenius cycler set or a manual pd bag for a pd treatment) is cleaned with alcavis for two minutes upon connection only.The nurse stated the patient is educated, trained, and performs this procedure.Per the nurse, the red end of the stay safe extension set (the end which connected to the patient¿s pd catheter) is cleaned daily with soap and water by the patient.Additionally, the red end of the stay safe extension set is cleaned with betadine when it is initially connected to the pd catheter copak adaptor.The nurse reiterated that the observed cracks occurred at the red end of the stay safe extension set.

• 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: 18697311
• Report Number: 3023981687-2024-00050
• Device Sequence Number: 12851307
• Product Code: KDJ
• UDI-Device Identifier: 00840861100767
• UDI-Public: 00840861100767
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024
• Report Date (Section F): 02/13/2024

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?: Yes
• Operator of Device: Lay User/Patient
• 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: 01/24/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 02/13/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 05/09/2024
• 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: 62 YR
• Patient Sex: Male
• Date Report Sent to FDA: 02/13/2024