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

Catalog 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	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak on the adapter connection after readjusting the last bag during their pd treatment.The patient reported receiving a supply bag lines are blocked alarm during dwell 5 of 5 of treatment.There were air bubbles in the supply bag (sb) line.It is unknown at which point in therapy the leak may have begun.The cause of the leak was a crack on the adapter.The patient cancelled treatment.It was reported that an alternate treatment option was not available.Additional information was requested, however to date has not been provided.
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 on the adapter connection after readjusting the last bag during their pd treatment.The patient reported receiving a supply bag lines are blocked alarm during dwell 5 of 5 of treatment.There were air bubbles in the supply bag (sb) line.It is unknown at which point in therapy the leak may have begun.The cause of the leak was a crack on the adapter.The patient cancelled treatment.It was reported that an alternate treatment option was not available.Upon follow up, the pd nurse reported it is unknown if there were any leaks on the cycler set or cycler.The patient does use baxter for the last bag of treatment.There have been no further issues with any fresenius products reported since the incident.There was no change in the patient's status.The patient completed treatment on the day of the event on the cycler without the last bag option.The patient has recovered from the incident.The patient discarded the safe lock adapter and it is no longer available for physical analysis.
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 on the adapter connection after readjusting the last bag during their pd treatment.The patient reported receiving a supply bag lines are blocked alarm during dwell 5 of 5 of treatment.There were air bubbles in the supply bag (sb) line.It is unknown at which point in therapy the leak may have begun.The cause of the leak was a crack on the adapter.The patient cancelled treatment.It was reported that an alternate treatment option was not available.Upon follow up, the pd nurse reported it is unknown if there were any leaks on the cycler set or cycler.The patient does use baxter for the last bag of treatment.There have been no further issues with any fresenius products reported since the incident.There was no change in the patient's status.The patient completed treatment on the day of the event on the cycler without the last bag option.The patient has recovered from the incident.The patient discarded the safe lock adapter and it is no longer available for physical analysis.
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
• 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: 19332957
• Report Number: 0008030665-2024-00466
• Device Sequence Number: 15157618
• Product Code: KDJ
• UDI-Device Identifier: 00840861100811
• UDI-Public: 00840861100811
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2024

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: 09/30/2024
• Device Catalogue Number: 050-95018
• Device Lot Number: 23LR08104
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 06/07/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 05/28/2024; 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Sex: Male