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

Model Number	STAY
Medical Device Problem Codes	Crack (1135); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); High Blood Pressure/ Hypertension (1908); Peritonitis (2252); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	05/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 3/jun/2024 during follow-up, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a stay safe catheter extension set for renal replacement therapy (rrt) contracted peritonitis after discovering a cracked stay safe catheter extension.No additional information was provided during intake.Follow-up with the patient¿s primary pd registered nurse (pdrn) revealed the patient was undergoing ccpd on 26/may/2024, when he noticed the bed was wet.It was discovered the pd catheters¿ (not a fresenius product) stay safe extension set had cracked and was leaking dialysate (replaced 27/may/2024).The cause of the cracked extension set remains unknown.The patient called the on-call pdrn who instructed the patient to wrap the extension set in sterile gauze and report to the clinic on monday 27/may/2024.The patient presented to the outpatient home dialysis clinic with cloudy peritoneal effluent fluid and a peritoneal effluent fluid culture and cell count were obtained (wbc cell count = 2278 u/l, polymorphs = 79%) and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) cefepime 2000 mg daily x 14 days; however, on 30/may/2024, the patient contacted the pdrn reporting mild abdominal pain, cramping, and hypertension (blood pressure = 190/100).The patient was instructed to go to the emergency room and was admitted for peritonitis and hypertension.The patient continued to receive cefepime while hospitalized, however it was transitioned to intravenous (iv) administration instead of ip.The patient¿s hypertension was believed to be stress related due to the peritonitis and resolved without medicinal/medical intervention.On 31/may/2024, the patient¿s peritoneal effluent fluid cultures were negative for growth, however the patient will continue the antibiotic course until completed.The patient is recovering from the events and was discharged in stable condition on (b)(6) 2024.The cause of the peritonitis was attributed to the breach in sterility due to the cracked stay safe extension set.The patient continued to undergo ccpd therapy while hospitalized and resumed utilizing the same liberty select cycler following discharge without reported issue.
Event or Problem Description
On (b)(6) 2024 during follow-up, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a stay safe catheter extension set for renal replacement therapy (rrt) contracted peritonitis after discovering a cracked stay safe catheter extension.No additional information was provided during intake.Follow-up with the patient¿s primary pd registered nurse (pdrn) revealed the patient was undergoing ccpd on (b)(6) 2024, when he noticed the bed was wet.It was discovered the pd catheters¿ (not a fresenius product) stay safe extension set had cracked and was leaking dialysate (replaced (b)(6) 2024).The cause of the cracked extension set remains unknown.The patient called the on-call pdrn who instructed the patient to wrap the extension set in sterile gauze and report to the clinic on monday (b)(6) 2024.The patient presented to the outpatient home dialysis clinic with cloudy peritoneal effluent fluid and a peritoneal effluent fluid culture and cell count were obtained (wbc cell count = 2278 u/l, polymorphs = 79%) and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) cefepime 2000 mg daily x 14 days; however, on (b)(6) 2024, the patient contacted the pdrn reporting mild abdominal pain, cramping, and hypertension (blood pressure = 190/100).The patient was instructed to go to the emergency room and was admitted for peritonitis and hypertension.The patient continued to receive cefepime while hospitalized, however it was transitioned to intravenous (iv) administration instead of ip.The patient¿s hypertension was believed to be stress related due to the peritonitis and resolved without medicinal/medical intervention.On (b)(6) 2024, the patient¿s peritoneal effluent fluid cultures were negative for growth, however the patient will continue the antibiotic course until completed.The patient is recovering from the events and was discharged in stable condition on (b)(6) 2024.The cause of the peritonitis was attributed to the breach in sterility due to the cracked stay safe extension set.The patient continued to undergo ccpd therapy while hospitalized and resumed utilizing the same liberty select cycler following discharge without reported issue.
Additional Manufacturer Narrative
Additional information provided in b1, d4, d10, and h6.

• 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: 19513644
• Report Number: 3023981687-2024-00151
• Device Sequence Number: 19842572
• Product Code: KDJ
• UDI-Device Identifier: 00840861100798
• UDI-Public: 00840861100798
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/15/2024
• Report Date (Section F): 10/15/2024

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 Model Number: STAY
• Device Catalogue Number: 050-95005
• Device Lot Number: 24AR08121
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/03/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 10/15/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 10/15/2024
• 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 SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Date Report Sent to FDA: 10/15/2024