MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 8 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15402-E
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "noticed that when flushing cns in the distal brown lumen that nothing would flush upon inspection the tube closest to the white hub where the two lumen jucted looks like tubing inflated.The cvc needed to be removed." additional information has been requested from the customer; however further details has not been provided at this time.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one, 2-lumen cvc for evaluation.Signs of use were observed inside the catheter body.Visual analysis revealed the distal extension line stretched/ballooned towards the juncture hub.A dent was additionally observed on the ballooned area, which appears consistent with damage due to an activated slide clamp.The observed damage appears consistent with unintention-al over pressurization of the extension line during use.The stretched portion of the extension line measured 2-7mm from the juncture hub.The distal extension line outer diameter in a non-stretched area measured 0.0870", which is within the specification limits of 0.084"-0.088" per product drawing.The distal extension line inner diameter within the luer hub measured 0.057", which is within the specification limits of 0.055"-0.059" per product drawing.The catheter was functionally tested per the product in-structions-for-use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the extension lines were flushed using a lab inventory 10ml syringe filled with water.The distal extension line could not ini-tially be flushed due to a blockage composed of biological material.Once the biological material was removed, the extension line flushed as intended.The blockage observed in the extension line could have contributed to the event reported by the customer.A device history record review was per-formed, and no relevant findings were identified.The ifu provided with this kit informs the user, "warning: open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the customer report of a stretched/ballooned extension line was confirmed through complaint inves-tigation of the returned sample.V isual inspection revealed the distal extension line was partially stretched/ballooned.Despite this, the catheter met all relevant dimensional requirements, and a de-vice history record review was performed with no relevant findings to suggest a manufacturing is-sue.Over pressurization of the line can occur due to multiple causes including internal occlusions, flushing with an activated slide clamp, or kinking of the catheter.As a part of this complaint, a blockage was identified within the distal lumen.Based on these circumstances, unintentional use error (overpressure) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "noticed that when flushing cns in the distal brown lumen that nothing would flush upon inspection the tube closest to the white hub where the two lumen jucted looks like tubing inflated.The cvc needed to be removed." additional information has been requested from the customer, however further details has not been provided at this time.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 8 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20384495
• Report Number: 9680794-2024-00981
• Device Sequence Number: 18144707
• Product Code: DQY
• UDI-Device Identifier: 10801902099645
• UDI-Public: (01)10801902099645(11)231113(17)270531(10)14F23L0052(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CS-15402-E
• Device Lot Number: 14F23L0052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown