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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Abdominal Distention (2601); Hypervolemia (2664)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical investigation: based on the required information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.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 was admitted to the hospital due to abdominal distension.Upon follow up with the patient¿s pdrn, it was reported this patient was hospitalized on (b)(6) 2024 for fluid retention due to noncompliance to pd orders.It was explained the patient broke the blue connector from his extension set into his stay-safe organizer when applying too much force and neglected to report this event to the outpatient clinic.As a result, the patient skipped multiple pd treatments and experienced fluid retention with abdominal distention.It was affirmed the patient was trained on manual exchanges and had the appropriate supplies at the time of this event.The patient has been able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient was also diagnosed with hyperglycemia during this admission that was attributed to comorbidities unrelated to pd therapy or the use of any fresenius product(s) or device(s).Additionally, it was confirmed the patient¿s fluid retention, abdominal distention and associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient¿s pd catheter (not a fresenius product) was determined to be patent with no deficiency during this hospitalization.The patient is recovering from this event while awaiting discharge to home.The patient will continue ccpd therapy on the same liberty select cycler at home post-discharge.Based on the required information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.
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.As there is no allegation related to product manufacture, the complaint is deemed as unconfirmed and completion of the device history record (dhr) review is not required as it is unrelated to the investigation.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 was admitted to the hospital due to abdominal distension.Upon follow up with the patient¿s pdrn, it was reported this patient was hospitalized on (b)(6) 2024 for fluid retention due to noncompliance to pd orders.It was explained the patient broke the blue connector from his extension set into his stay-safe organizer when applying too much force and neglected to report this event to the outpatient clinic.As a result, the patient skipped multiple pd treatments and experienced fluid retention with abdominal distention.It was affirmed the patient was trained on manual exchanges and had the appropriate supplies at the time of this event.The patient has been able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient was also diagnosed with hyperglycemia during this admission that was attributed to comorbidities unrelated to pd therapy or the use of any fresenius product(s) or device(s).Additionally, it was confirmed the patient¿s fluid retention, abdominal distention and associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient¿s pd catheter (not a fresenius product) was determined to be patent with no deficiency during this hospitalization.The patient is recovering from this event while awaiting discharge to home.The patient will continue ccpd therapy on the same liberty select cycler at home post-discharge.Based on the required information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.

• 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: 20666824
• Report Number: 0008030665-2024-01052
• Device Sequence Number: 7286119
• Product Code: KDJ
• UDI-Device Identifier: 00840861100798
• UDI-Public: 00840861100798
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 12/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-95005
• Device Lot Number: 24JR08095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 86 KG