MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95004
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: h6 health effect impact code.
Event or Problem Description
A peritoneal dialysis (pd) patient reported a fluid leak was discovered during fill 1 of 4 of treatment.The patient was connected during the incident.Fluid was noted to be leaking from the patient connector push pin.The patient explained that a portion of the catheter connection had broken.The patient was requested to reset up the cycler at at step 7 the patient explained that a part of the connection on her catheter was broken, the patient was advised to contact the on-call registered nurse (rn).There was no patient injury noted during intake.Upon follow-up, the peritoneal dialysis registered nurse (pdrn) stated the patient used a 12-inch stay safe luer lock catheter extension which disconnected from the tubing line and luer lock during an unknown phase and cycle of treatment and caused a fluid leak to occur.The patient was able to clamp off the line and was unable to complete their remaining treatment on the night of the reported event.Per pdrn the patient was requested to come into the clinic the following morning and was prescribed prophylactic medication (vancomycin, 2g, intraperitoneal (ip) as a precaution.Per pdrn the patient's extension set was replaced.The patient did not develop any symptoms, adverse events, injuries, or require any other medical intervention as a result of the reported event.The patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The pdrn stated the extension set was discarded and was not available to be returned to the manufacturer for physical evaluation.
Event or Problem Description
A peritoneal dialysis (pd) patient reported a fluid leak was discovered during fill 1 of 4 of treatment.The patient was connected during the incident.Fluid was noted to be leaking from the patient connector push pin.The patient explained that a portion of the catheter connection had broken.The patient was requested to reset up the cycler at at step 7 the patient explained that a part of the connection on her catheter was broken, the patient was advised to contact the on-call registered nurse (rn).There was no patient injury noted during intake.Upon follow-up, the peritoneal dialysis registered nurse (pdrn) stated the patient used a 12-inch stay safe luer lock catheter extension which disconnected from the tubing line and luer lock during an unknown phase and cycle of treatment and caused a fluid leak to occur.The patient was able to clamp off the line and was unable to complete their remaining treatment on the night of the reported event.Per pdrn the patient was requested to come into the clinic the following morning and was prescribed prophylactic medication (vancomycin, 2g, intraperitoneal (ip) as a precaution.Per pdrn the patient's extension set was replaced.The patient did not develop any symptoms, adverse events, injuries, or require any other medical intervention as a result of the reported event.The patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The pdrn stated the extension set was discarded and was not available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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 reported a fluid leak was discovered during fill 1 of 4 of treatment.The patient was connected during the incident.Fluid was noted to be leaking from the patient connector push pin.The patient explained that a portion of the catheter connection had broken.The patient was requested to reset up the cycler at at step 7 the patient explained that a part of the connection on her catheter was broken, the patient was advised to contact the on-call registered nurse (rn).There was no patient injury noted during intake.Upon follow-up, the peritoneal dialysis registered nurse (pdrn) stated the patient used a 12-inch stay safe luer lock catheter extension which disconnected from the tubing line and luer lock during an unknown phase and cycle of treatment and caused a fluid leak to occur.The patient was able to clamp off the line and was unable to complete their remaining treatment on the night of the reported event.Per pdrn the patient was requested to come into the clinic the following morning and was prescribed prophylactic medication (vancomycin, 2g, intraperitoneal (ip) as a precaution.Per pdrn the patient's extension set was replaced.The patient did not develop any symptoms, adverse events, injuries, or require any other medical intervention as a result of the reported event.The patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The pdrn stated the extension set was discarded and was not available to be returned to the manufacturer for physical evaluation.

• Brand Name: STAY SAFE/LUER LOCK CATHETER EXT. 12 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: 19611945
• Report Number: 0008030665-2024-00559
• Device Sequence Number: 17718597
• Product Code: KDJ
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024

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: 02/07/2024
• Device Catalogue Number: 050-95004
• Device Lot Number: 24BR08066
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2024
• Supplement Date Received by Manufacturer: 07/01/2024; 07/16/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/01/2024; 07/16/2024
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; PD SOLUTION; PD SOLUTION; PD SOLUTION
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 99 KG