MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the patient developed fever associated with bacteremia due to gram-negative klebsiella pneumoniae (multi-sensitive), requiring adjustment of antibiotic therapy and removal of the central venous access.During placement of a new central venous line, the patient developed a left hemothorax associated with hypovolemic shock due to a "defective device".Associated mdr numbers include: 9680794-2025-00832 and 9680794-2025-00883.
Event or Problem Description
It was reported "the patient developed fever associated with bacteremia due to gram-negative klebsiella pneumoniae (multi-sensitive), requiring adjustment of antibiotic therapy and removal of the central venous access.During placement of a new central venous line, the patient developed a left hemothorax associated with hypovolemic shock due to a "defective device".Associated mdr numbers include: 9680794-2025-00832 and 9680794-2025-00883.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The photo shows the guide wire advanced through the catheter and the guide wire was unraveled towards the distal end past the distal tip of the catheter.The complaint of a catheter-related infection was not able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.Clinical and medical affairs (cma) was consulted as a part of this investigation.Cma stated, "regarding the reported central line-associated bloodstream infection (clabsi), this occurred in a severely immunocompromised pediatric oncology patient with prolonged central venous access and dependence on parenteral nutrition, clinical factors that significantly increase susceptibility to infection.The infection was due to klebsiella pneumoniae and required antibiotic treatment and catheter removal, with subsequent stabilization of the patient.Based on the timing and clinical circumstances, this infection is best explained by patient-related factors and hospital course rather than any device performance concern, and it is not causally linked to the mechanical guidewire event." in summary, cma suggests the clabsi reflects a known complication in an immunocompromised host with prolonged line use.Additionally, ten years of complaint history for finished good cs-14402 were reviewed and there were no confirmed reports of catheter-related infection.A device history record review was performed, and no relevant findings were identified.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, "regarding the reported central line associated bloodstream infection (clabsi), this occurred in a severely immunocompromised pediatric oncology patient with prolonged central venous access and dependence on parenteral nutrition, clinical factors that significantly increase susceptibility to infection.The infection was due to klebsiella pneumoniae and required antibiotic treatment and catheter removal, with subsequent stabilization of the patient.Based on the timing and clinical circumstances, this infection is best explained by patient-related factors and hospital course rather than any device performance concern, and it is not causally linked to the mechanical guidewire event." based on these circumstances, the root cause of the reported event cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23476722
• Report Number: 9680794-2025-00883
• Device Sequence Number: 21389177
• Product Code: DQY
• UDI-Device Identifier: 00801902102140
• UDI-Public: (01)00801902102140(11)230718(17)271130(10)14F23G0103(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: CS-14402
• Device Lot Number: 14F23G0103
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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 Age: 5 YR
• Patient Sex: Male