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 Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Abdominal Pain (1685); Peritonitis (2252)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A voluntary medwatch mw5119435 was received.The report stated that the catheter extension set with luer-lock tip fell off.The patient noticed a leak and as a result was hospitalized.Additional information was provided by follow-up with the peritoneal dialysis registered nurse (pdrn).The patient was seen in the pd clinic on (b)(6) 2023 after the cap on the luer-lock end of the catheter extension set fell off.The patient noted a leak after the cap fell off.The patient was not in active treatment at the time of the cap falling off.While at the clinic, the patient¿s extension set was exchanged for a new one.The extension set was discarded.The patient was administered antibiotics (drug, route, and dose not provided).On (b)(6) 2023 the patient presented to the hospital with complaints of abdominal pain.The patient was admitted with a diagnosis of peritonitis.A pd effluent culture resulted positive for staphylococcus aureus.The patient was prescribed antibiotic therapy with vancomycin (route, dose, frequency, and duration unknown).The patient was discharged on (b)(6) 2023.
Additional Manufacturer Narrative
Clinical review: there is a temporal and probable causal relationship between the patient¿s peritonitis with hospitalization and the cap on the luer-lock end of the stay safe® catheter extension set falling off.The culture result of staphylococcus aureus supports that there was most likely a touch contamination of the luer-lock end of the extension set after the cap fell off.Peritonitis is most often due to contamination with pathogenic skin bacteria, with staphylococcus epidermidis and staphylococcus aureus accounting for the majority of cases.(john m burkart, 2023) it is unknown if the patient did not secure the cap correctly or if there was a product defect that resulted in the cap falling off.The clinic disposed of the extension set when the patient came to the clinic and they replaced it for a new one.Therfore, no evaluation could be conducted by the manufacturer.Based on the available information, the stay¿safe® catheter extension set with luer-lock is most likely the cause of the patient¿s adverse event and cannot be excluded as the cause of the patient¿s peritonitis event with hospitalization.Should additional information become available related to a fresenius device(s) and/or product(s), please re-submit for a clinical review and the need for a clinical investigation will be reassessed accordingly.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 voluntary medwatch (b)(4) was received.The report stated that the catheter extension set with luer-lock tip fell off.The patient noticed a leak and as a result was hospitalized.Additional information was provided by follow-up with the peritoneal dialysis registered nurse (pdrn).The patient was seen in the pd clinic on (b)(6) 2023 after the cap on the luer-lock end of the catheter extension set fell off.The patient noted a leak after the cap fell off.The patient was not in active treatment at the time of the cap falling off.While at the clinic, the patient¿s extension set was exchanged for a new one.The extension set was discarded.The patient was administered antibiotics (drug, route, and dose not provided).On (b)(6) 2023 the patient presented to the hospital with complaints of abdominal pain.The patient was admitted with a diagnosis of peritonitis.A pd effluent culture resulted positive for staphylococcus aureus.The patient was prescribed antibiotic therapy with vancomycin (route, dose, frequency, and duration unknown).The patient was discharged on (b)(6) 2023.
Additional Manufacturer Narrative
Correction: h.6.
Event or Problem Description
A voluntary medwatch mw5119435 was received.The report stated that the catheter extension set with luer-lock tip fell off.The patient noticed a leak and as a result was hospitalized.Additional information was provided by follow-up with the peritoneal dialysis registered nurse (pdrn).The patient was seen in the pd clinic on 05/jul/2023 after the cap on the luer-lock end of the catheter extension set fell off.The patient noted a leak after the cap fell off.The patient was not in active treatment at the time of the cap falling off.While at the clinic, the patient¿s extension set was exchanged for a new one.The extension set was discarded.The patient was administered antibiotics (drug, route, and dose not provided).On 07/jul/2023 the patient presented to the hospital with complaints of abdominal pain.The patient was admitted with a diagnosis of peritonitis.A pd effluent culture resulted positive for staphylococcus aureus.The patient was prescribed antibiotic therapy with vancomycin (route, dose, frequency, and duration unknown).The patient was discharged on 10/jul/2023.

• 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: 17541916
• Report Number: 0008030665-2023-00744
• Device Sequence Number: 20448168
• Product Code: KDJ
• UDI-Device Identifier: 00840861100798
• UDI-Public: 00840861100798
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 10/12/2023

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 050-95005
• Device Lot Number: 22SR08086
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 10/12/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 10/03/2023; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 90 KG