MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. SAFE LOCK APD LUER LOCK CONNECTOR; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Model Number	050-95018
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak during dwell 4 of their pd treatment.The fluid leaked from the baxter adapter connection.There were no alarms prior to discovering the leak.The cause of the leak is unknown.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).Additional information was requested, however to date has not been provided.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak during dwell 4 of their pd treatment.The fluid leaked from the baxter adapter connection.There were no alarms prior to discovering the leak.The cause of the leak is unknown.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).Additional information was requested, however to date has not been provided.
Additional Manufacturer Narrative
Plant investigation: the complaint sample is not available for manufacturer physical evaluation.No product will be returned from the distribution center to be analyzed since the lot number is unknown.Additionally, no information was found on the sap system regarding the customer's shipment history of this product.Without sample availability, a lot number, or a shipment history, the alleged event could not be confirmed.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.

• Brand Name: SAFE LOCK APD LUER LOCK CONNECTOR
• 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: 17371648
• Report Number: 0008030665-2023-00657
• Device Sequence Number: 11708419
• Product Code: KDJ
• UDI-Device Identifier: 00840861100811
• UDI-Public: 00840861100811
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K124024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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 Model Number: 050-95018
• Device Catalogue Number: 050-95018
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 09/11/2023
• 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
• Patient Sex: Unknown