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	05/31/2024
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
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak between the extension set and catheter during their pd treatment.Fluid was noted to be squirting from the catheter area.No fluid came in contact with the cycler.The patient reported receiving an air detected in cassette alarm during drain 1 of 3 of treatment and the treatment was cancelled.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, it was confirmed that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient is continuing peritoneal dialysis therapy with no further issues.The cycler set and extension set used by the patient were discarded and is not available for return for physical evaluation by the manufacturer.
Additional Manufacturer Narrative
Corrected information provided in d1 and d4.Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.At this time a manufacturing review was performed to verify product availability for alternate samples at the distribution centers.According to the review no product is available of the lots delivered to the patient, on distribution centers to be analyzed.The entire lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak between the extension set and catheter during their pd treatment.Fluid was noted to be squirting from the catheter area.No fluid came in contact with the cycler.The patient reported receiving an air detected in cassette alarm during drain 1 of 3 of treatment and the treatment was cancelled.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, it was confirmed that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient is continuing peritoneal dialysis therapy with no further issues.The cycler set and extension set used by the patient were discarded and is not available for return for physical evaluation by the manufacturer.

• 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: 19487100
• Report Number: 0008030665-2024-00511
• Device Sequence Number: 12765182
• Product Code: KDJ
• UDI-Device Identifier: 00840861100798
• UDI-Public: 00840861100798
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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 Catalogue Number: 050-95005
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/01/2024
• 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
• Patient Sex: Male