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

Model Number	050-95004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is a temporal relationship between pd therapy utilizing the stay safe luer lock catheter extension set and the patient event of an er visit due to a hole in the set and the patient¿s temporary change in modality.However, it is unknown how the patient obtained a hole in the tubing of the set.The patient did not report that the tubing had a hole prior to use.It is unknown if the patient required any medical intervention related to the reported hole in the catheter extension set tubing in addition to the change in modality.It is also unknown if the patient retained the set for return to the manufacturer for evaluation.Based on the limited information, it cannot be concluded if the reported hole in the patient¿s pd catheter extension set caused or contributed to the patient¿s temporary change in modality.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
The peritoneal dialysis (pd) patient contacted fresenius technical support during dwell 3 of 6 of treatment on the liberty select cycler to report that a hole was found in their catheter line and request assistance with canceling treatment to go to the emergency room (er).Fresenius technical support assisted the patient with canceling treatment on the cycler.Upon initial follow-up it was reported that the patient is temporarily completing hemodialysis for approximately two weeks.No additional information was known related to the er visit or any medical intervention that could have been provided to the patient.Attempts to obtain additional information were unsuccessful.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review 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
The peritoneal dialysis (pd) patient contacted fresenius technical support during dwell 3 of 6 of treatment on the liberty select cycler to report that a hole was found in their catheter line and request assistance with canceling treatment to go to the emergency room (er).Fresenius technical support assisted the patient with canceling treatment on the cycler.Upon initial follow-up it was reported that the patient is temporarily completing hemodialysis for approximately two weeks.No additional information was known related to the er visit or any medical intervention that could have been provided to the patient.Attempts to obtain additional information were unsuccessful.

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 1100 e. military hwy, suite c; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15670458
• Report Number: 0008030665-2022-01238
• Device Sequence Number: 20426171
• Product Code: KDJ
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 050-95004
• Device Catalogue Number: 050-95004
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/11/2022
• 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: Initial
• 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 Sex: Unknown