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	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A peritoneal dialysis (pd) patient reported the patient became disconnected from the patient line during an unknown phase and cycle of treatment.The patient's pd catheter was still intact and the patient was no longer connected at the time of the call.The patient knew how to perform continuous ambulatory peritoneal dialysis (capd) therapy.The patient was advised to close all clamps and let the peritoneal dialysis registered nurse (pdrn) know the situation.Upon follow-up, the pdrn confirmed the reported event.The pdrn stated the patient used a 18-inch stay safe luer lock catheter extension which disconnected from the patient line of the cycler set during an unknown phase and cycle of treatment and caused a fluid leak to occur.It is unknown how the disconnection occurred, but the pdrn suspected the patient may not have properly tightened the connection.The patient reverted to manuals to complete their remaining treatment.Per pdrn the patient was requested to come into the clinic the same morning and was prescribed prophylactic medication (vancomycin, 2g, intraperitoneal (ip) as a precaution.Per pdrn the patient's extension set was also replaced as a pre-caution.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 and cycler set were discarded and were 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: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of 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
A peritoneal dialysis (pd) patient reported the patient became disconnected from the patient line during an unknown phase and cycle of treatment.The patient's pd catheter was still intact and the patient was no longer connected at the time of the call.The patient knew how to perform continuous ambulatory peritoneal dialysis (capd) therapy.The patient was advised to close all clamps and let the peritoneal dialysis registered nurse (pdrn) know the situation.Upon follow-up, the pdrn confirmed the reported event.The pdrn stated the patient used a 18-inch stay safe luer lock catheter extension which disconnected from the patient line of the cycler set during an unknown phase and cycle of treatment and caused a fluid leak to occur.It is unknown how the disconnection occurred, but the pdrn suspected the patient may not have properly tightened the connection.The patient reverted to manuals to complete their remaining treatment.Per pdrn the patient was requested to come into the clinic the same morning and was prescribed prophylactic medication (vancomycin, 2g, intraperitoneal (ip) as a precaution.Per pdrn the patient's extension set was also replaced as a pre-caution.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 and cycler set were discarded and were not available to be returned to the manufacturer for physical evaluation.

• 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: 18773351
• Report Number: 0008030665-2024-00208
• Device Sequence Number: 12697492
• Product Code: KDJ
• UDI-Device Identifier: 00840861100798
• UDI-Public: 00840861100798
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: 02/21/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/21/2024
• 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: LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; PD SOLUTION; PD SOLUTION
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 183 KG