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

Catalog Number	050-95005
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A peritoneal dialysis (pd) patient reported a fluid leak was discovered during dwell 1 of 4 of treatment.The patient was connected during the incident.Fluid leaked from the patient catheter line.There were no alarms or warnings prior to or after the leak.Fluid was not discovered in the pump module area or on the external of the cassette.The patient was assisted with cancelling treatment.The patient was to contact the peritoneal dialysis registered nurse (pdrn).There was no patient injury noted at intake.Upon follow-up, the pdrn confirmed the reported event.The pdrn stated the patient used a 18-inch stay safe luer lock catheter extension which began leaking from a pinhole in the tubing line near the connection point to the patient line of the cycler set during an unknown phase and cycle of treatment.It is unknown how the pinhole or leak occurred.The patient clamped off the extension set and discontinued treatment for the evening, and came into the clinic the following morning for fluid culture and replacement of the catheter extensions set.Per pdrn the patient was prescribed prophylactic medication (vancomycin, 2g, intraperitoneal (ip) as a precaution.The patient fluid cultures remained negative and the patient did not develop any symptoms, adverse events, injuries, or require any other medical intervention as a result of the reported event.The patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The pdrn stated the extension set was discarded and was no longer available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Event or Problem Description
A peritoneal dialysis (pd) patient reported a fluid leak was discovered during dwell 1 of 4 of treatment.The patient was connected during the incident.Fluid leaked from the patient catheter line.There were no alarms or warnings prior to or after the leak.Fluid was not discovered in the pump module area or on the external of the cassette.The patient was assisted with cancelling treatment.The patient was to contact the peritoneal dialysis registered nurse (pdrn).There was no patient injury noted at intake.Upon follow-up, the pdrn confirmed the reported event.The pdrn stated the patient used a 18-inch stay safe luer lock catheter extension which began leaking from a pinhole in the tubing line near the connection point to the patient line of the cycler set during an unknown phase and cycle of treatment.It is unknown how the pinhole or leak occurred.The patient clamped off the extension set and discontinued treatment for the evening, and came into the clinic the following morning for fluid culture and replacement of the catheter extensions set.Per pdrn the patient was prescribed prophylactic medication (vancomycin, 2g, intraperitoneal (ip) as a precaution.The patient fluid cultures remained negative and the patient did not develop any symptoms, adverse events, injuries, or require any other medical intervention as a result of the reported event.The patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The pdrn stated the extension set was discarded and was no longer available to be returned to the manufacturer for physical evaluation.

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 22784221
• Report Number: 0008030665-2025-01857
• Device Sequence Number: 13228842
• Product Code: KDJ
• UDI-Device Identifier: 00840861100798
• UDI-Public: 00840861100798
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-95005
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; PD SOLUTION; PD SOLUTION
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 91 KG