MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. SAFE LOCK APD LUER LOCK CONNECTOR; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Model Number	050-95018
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	10/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical investigation: there is a temporal relationship between pd therapy utilizing the fresenius apd luer-lock adapter and the peritonitis event with hospitalization and subsequent removal of the pd catheter with transition to in-center hd.Although there is no documentation that the apd luer-lock adapter did not perform as expected, the patient did not follow the product insert instructions and reused the adapter multiple times resulting in the peritonitis.The insert warns not to reuse the sterile single-use product as it can increase the risk for infection.The organism of stenotrophomonas maltophilia is frequently isolated in water and soil and known to colonize in patient¿s bodily fluids such as respiratory aerosols, urine, and wound exudates.Based on the available information and no allegation or evidence of a malfunction or deficiency, the apd luer lock can be excluded as causing the patient¿s peritonitis event.Although the product instructions clearly state this is a one-time use product, the patient did not follow the product instructions resulting in the adverse event.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 initially admitted to the hospital with abdominal pain and cloudy pd effluent.The patient was diagnosed with peritonitis.The patient was discharged on (b)(6) 2021.The hospital course is unknown.On (b)(6) 2021 the patient was seen at the pd clinic with severe abdominal pain and cloudy pd effluent.Cultures were obtained which resulted positive for stenotrophomonas maltophilia.It was determined the patient had not recovered from the initial peritonitis hospitalization and was diagnosed with peritonitis (relapsing).The patient¿s antibiotic therapy is unknown.On (b)(6) 2021 the patient was hospitalized for the removal of the pd catheter (not a fresenius product) and is currently completing in-center hemodialysis (hd).It was determined the cause of the peritonitis was the patient reusing the same fresenius apd luer-lock adapter multiple times.No additional information was obtained.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient was initially admitted to the hospital with abdominal pain and cloudy pd effluent.The patient was diagnosed with peritonitis.The patient was discharged on (b)(6) 2021.The hospital course is unknown.On (b)(6) 2021 the patient was seen at the pd clinic with severe abdominal pain and cloudy pd effluent.Cultures were obtained which resulted positive for stenotrophomonas maltophilia.It was determined the patient had not recovered from the initial peritonitis hospitalization and was diagnosed with peritonitis (relapsing).The patient¿s antibiotic therapy is unknown.On (b)(6) 2021 the patient was hospitalized for the removal of the pd catheter (not a fresenius product) and is currently completing in-center hemodialysis (hd).It was determined the cause of the peritonitis was the patient reusing the same fresenius apd luer-lock adapter multiple times.No additional information was obtained.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review could not be performed on the products shipped to the patient due to the patient information being unknown.A review of the user guide was performed.The user guide states as a warning before starting the treatment, ¿you must use aseptic technique as directed by your pd nurse to prevent infection¿.At this time, the reported incident could be attributed to end user error in accordance with the complaint description.As the complaint sample was not available a physical evaluation could not be performed, therefore the alleged event could not be confirmed.

• Brand Name: SAFE LOCK APD LUER LOCK CONNECTOR
• 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; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13026529
• Report Number: 8030665-2021-01871
• Device Sequence Number: 12123120
• Product Code: KDJ
• UDI-Device Identifier: 00840861100811
• UDI-Public: 00840861100811
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K124024
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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 Model Number: 050-95018
• Device Catalogue Number: 050-95018
• 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: 12/08/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/06/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown