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	09/16/2021
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 the safe lock apd luer lock connector during their pd treatment.The patient reported receiving a supply bag lines are blocked message during dwell 6 of 6 of treatment.It is unknown at which point in therapy the leak may have begun.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).It was reported that an alternate treatment option was available.Upon follow up, the patient stated that the fluid leak occurred on 09/16/2021.There were supply bag lines are blocked messages during dwell 6 of 6 of treatment and upon looking around, the patient noticed that the luer lock connector was leaking.The patient stated that the tubing of the luer lock connecter was leaking and confirmed that no fluid got in or near the cycler and had only gotten onto their floor.The patient stated that the baxter bag was not leaking or damaged and confirmed that only the luer lock connector was leaking.The patient stated that the tubing was leaking, but they could not find the hole it was leaking from.The cause of the leak was unknown.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported events.The patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and was able to complete peritoneal dialysis treatment manually on the night of the reported event.The cassette used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak the safe lock apd luer lock connector during their pd treatment.The patient reported receiving a supply bag lines are blocked message during dwell 6 of 6 of treatment.It is unknown at which point in therapy the leak may have begun.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).It was reported that an alternate treatment option was available.Upon follow up, the patient stated that the fluid leak occurred on (b)(6)2021.There were supply bag lines are blocked messages during dwell 6 of 6 of treatment and upon looking around, the patient noticed that the luer lock connector was leaking.The patient stated that the tubing of the luer lock connecter was leaking and confirmed that no fluid got in or near the cycler and had only gotten onto their floor.The patient stated that the baxter bag was not leaking or damaged and confirmed that only the luer lock connector was leaking.The patient stated that the tubing was leaking, but they could not find the hole it was leaking from.The cause of the leak was unknown.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported events.The patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and was able to complete peritoneal dialysis treatment manually on the night of the reported event.The cassette used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.
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.

• 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
• MDR Report Key: 12506973
• Report Number: 8030665-2021-01485
• Device Sequence Number: 11746725
• Product Code: KDJ
• UDI-Device Identifier: 00840861100811
• UDI-Public: 00840861100811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/27/2021

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 Expiration Date: 03/31/2022
• Device Model Number: 050-95018
• Device Catalogue Number: 050-95018
• Device Lot Number: 21CR08135
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 09/27/2021
• 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: LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; PD SOLUTIONS; PD SOLUTIONS; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER; PD SOLUTIONS
• Patient Age: 73 YR
• Patient Weight: 90