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	01/31/2024
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
A peritoneal dialysis (pd) patient¿s pd nurse reported that during pd treatment there was a fluid leak encountered.Treatment was stopped and a hole was discovered under the white clamp on the extension set.The patient was prescribed prophylactic antibiotics.In a follow up, the nurse said there were no symptoms, adverse events, or injuries requiring medical intervention as a result of the reported event.The nurse did verify that the prophylactic treatment was administered.The cycler set is available to return.
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
A peritoneal dialysis (pd) patient¿s pd nurse reported that during pd treatment there was a fluid leak encountered.Treatment was stopped and a hole was discovered under the white clamp on the extension set.The patient was prescribed prophylactic antibiotics.In a follow up, the nurse said there were no symptoms, adverse events, or injuries requiring medical intervention as a result of the reported event.The nurse did verify that the prophylactic treatment was administered.The cycler set is available to return.
Additional Manufacturer Narrative
Additional information: d.9.,h.3.Plant investigation: received one complaint sample without original package with product number 050-95005 from lot 23lr08099.The received complaint product sample was visually inspectioned according to bom 050-95005, however it was not found any holes or damaged to the tube that could cause a leak.The sample was received as is showed in the following photos.Due to the condition of the sample, it was not able to perform a functional test.A dhr (device history record) review was performed for the involved lot of the product and there were no non-conformances, deviations or any associated rework related with the alleged failure mode during the assembly process of the lot involved.All the applicable in-process and final inspection tests were found with acceptable results.
Event or Problem Description
A peritoneal dialysis (pd) patient¿s pd nurse reported that during pd treatment there was a fluid leak encountered.Treatment was stopped and a hole was discovered under the white clamp on the extension set.The patient was prescribed prophylactic antibiotics.In a follow up, the nurse said there were no symptoms, adverse events, or injuries requiring medical intervention as a result of the reported event.The nurse did verify that the prophylactic treatment was administered.The cycler set is available to return.

• 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: 18727207
• Report Number: 0008030665-2024-00181
• Device Sequence Number: 5805572
• Product Code: KDJ
• UDI-Device Identifier: 00840861100798
• UDI-Public: 00840861100798
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2024

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: 09/30/2026
• Device Catalogue Number: 050-95005
• Device Lot Number: 23LR08099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 02/21/2024; 07/05/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 02/29/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 80 KG