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

Model Number	050-95004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Peritonitis (2252)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 this male peritoneal dialysis (pd) patient contacted fresenius customer service.The patient stated that he thought he had ordered stay safe caps last year for when he traveled.However, he ended up in the hospital for eleven days with a diagnosis of peritonitis due to no caps.Customer service was unable to substantiate the report of ordering caps.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was traveling when he went to the hospital on (b)(6) 2022 with reports of abdominal pain and cloudy pd effluent.The patient was admitted to the hospital.A pd effluent culture was obtained, and the patient was initiated on antibiotic therapy.The patient was administered intraperitoneal (ip) vancomycin (dose, frequency, and duration unknown).The pd culture resulted in no growth.The patient was discharged on (b)(6) 2022.Upon discharge, the patient¿s antibiotic therapy was adjusted.The vancomycin was discontinued, and the patient was prescribed ip ceftazidime daily for 12 days (dose unknown).The suspected cause of the peritonitis is the patient not having the stay safe cap for the stay safe catheter extension set while traveling.The pdrn stated this is what the patient reported to the clinic; however, the pdrn could not confirm the report as the culture did not return any growth to determine an origin.The patient continued pd therapy utilizing the liberty select cycler during recovery.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. clinical review: there is a temporal and possible causal relationship between pd therapy utilizing the stay safe cap for the stay safe catheter extension set and the patient event of peritonitis with hospitalization.The patient reported that he had ordered caps for the stay safe catheter extension set prior to travel, but contracted peritonitis due to not having a cap on the extension set.There is no documentation of any order the patient placed for caps.It is unknown if the patient checked his supplies prior to leaving for travel.The pdrn could not confirm the patient¿s report of no stay safe cap available for the stay safe catheter extension set.The pd effluent culture was negative for growth and therefore the origin of the peritonitis could not be determined.It also cannot be confirmed if the initial cap fell off or the patient did not replace it with a new cap after treatment as the liberty select cycler user¿s guide instructs: carefully disconnect the patient line from your extension set and cap off with a new sterile stay safe cap.Based on the available information, the stay safe catheter extension set with stay safe cap cannot be excluded as the cause of the patient¿s peritonitis with hospitalization.
Additional Manufacturer Narrative
Correction provided in b1.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
On (b)(6) 2023 this male peritoneal dialysis (pd) patient contacted fresenius customer service.The patient stated that he thought he had ordered stay safe caps last year for when he traveled.However, he ended up in the hospital for eleven days with a diagnosis of peritonitis due to no caps.Customer service was unable to substantiate the report of ordering caps.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was traveling when he went to the hospital on (b)(6) 2022 with reports of abdominal pain and cloudy pd effluent.The patient was admitted to the hospital.A pd effluent culture was obtained, and the patient was initiated on antibiotic therapy.The patient was administered intraperitoneal (ip) vancomycin (dose, frequency, and duration unknown).The pd culture resulted in no growth.The patient was discharged on (b)(6) 2022.Upon discharge, the patient¿s antibiotic therapy was adjusted.The vancomycin was discontinued, and the patient was prescribed ip ceftazidime daily for 12 days (dose unknown).The suspected cause of the peritonitis is the patient not having the stay safe cap for the stay safe catheter extension set while traveling.The pdrn stated this is what the patient reported to the clinic; however, the pdrn could not confirm the report as the culture did not return any growth to determine an origin.The patient continued pd therapy utilizing the liberty select cycler during recovery.

• 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: 16242489
• Report Number: 0008030665-2023-00089
• Device Sequence Number: 6606108
• Product Code: KDJ
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/01/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 050-95004
• Device Catalogue Number: 050-95004
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 03/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male