MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CV-15703
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Sepsis (2067)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " the complaint received and described by our client was that after admitting 2 patients to the operation room and putting the catheter, they both developed sepsis.The client has carried biological test that showed the presence of serratia marcescens, they performed the same test on other patient after removing the catheter with the same batch number and found the same result." the patient undertook antibiotic therapy.The patient's current condition is reported as "fine".Associated mdr numbers include: 3006425876-2025-00898 and 3006425876-2025-00899.
Event or Problem Description
It was reported that " the complaint received and described by our client was that after admitting 2 patients to the operation room and putting the catheter, they both developed sepsis.The client has carried biological test that showed the presence of serratia marcescens, they performed the same test on other patient after removing the catheter with the same batch number and found the same result." the patient undertook antibiotic therapy.The patient's current condition is reported as "fine".Associated mdr numbers include: 3006425876-2025-00898 and 3006425876-2025-00899.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Clinical and medical affairs (cma) was consulted as part of this investigation.Cma stated, "the most likely cause of the reported infections is contamination originating from the clinical environment rather than an intrinsic defect or sterility failure of the catheter.The temporal clustering of two serratia marcescens infections in patients treated in the same operating room suggests a common external source, such as contaminated fluids, instruments, or surfaces.The device's validated terminal sterilization process provides a high sterility assurance level.Therefore, this event is assessed as most consistent with an extrinsic contamination source (user environment) rather than a device-related sterility failure." additionally, ten years of complaint history for finished good cv-15703 were reviewed and there were no confirmed reports of catheter-related infection.The instructions for use (ifu) provided with this kit warns the user, "do not reuse , reprocess or re-sterilize.Reuse of device creates a potential risk of serious injury and/or infection which may lead to death.Reprocessing of medical devices intended for single use only may result in degraded performance or a loss of functionality." the complaint of catheter related infection could not be confirmed based on the information provided and consultation with clinical and medical affairs (cma).Cma stated that it could not be confirmed that the infection was the result of the catheter.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23199423
• Report Number: 3006425876-2025-00899
• Device Sequence Number: 15972590
• Product Code: DQY
• UDI-Device Identifier: 10801902105339
• UDI-Public: (01)10801902105339(11)240506(17)281130(10)71F24D1569(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MO
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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
• Device Catalogue Number: CV-15703
• Device Lot Number: 71F24D1569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2024
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown