MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CA-27702
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that"13 dec 2023, the dilator tip was found damaged during use on the patient.
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened cvc kit for analysis.Signs of use in the form of biological material were observed on the dilator tip and inside the catheter body.This contradicts the customer report that the defect was observed prior to use.The customer was contacted to address the discrepancy of the signs of use and they confirmed that the defect was observed during use.Visual analysis revealed that the dilator tip was split/frayed.Microscopic examination confirmed the damage and revealed scratch marks adjacent to the damage.The appearance of the damage is consistent with damage resulting from undue force used during an attempted insertion.The dilator length measured 4", which is within the specification limits of 3 3/4"-4 1/4" per the dilator product drawing.The dilator outer diameter measured 0.112", which is within the specification limits of 0.111"-0.113" per the dilator extrusion product drawing.The dilator inner diameter at the proximal end measured 0.064", which is within the specification limits of 0.064"-0.067" per the dilator extrusion product drawing.The dilator inner diameter at the distal tip cannot be verified due to the severity of the damage.A lab inventory guide wire with a diameter of 0.032" was inserted through the dilator.Minor resistance was encountered at the tip; however, the guide wire passed through all other sections of the dilator with little to no issue.Performed per ifu statement , "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a damaged dilator tip was confirmed through complaint investigation.Visual analysis revealed that the dilator tip was split/frayed.Scratch marks were also noted adjacent to the damage.The appearance of the damage is consistent with damage resulting from undue force used during an attempted insertion.The dilator met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "13 dec 2023, the dilator tip was found damaged during use on the patient.

• Brand Name: ARROW CVC KIT: 2-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 18669422
• Report Number: 9680794-2024-00140
• Device Sequence Number: 12763034
• Product Code: FOZ
• UDI-Device Identifier: 10801902099263
• UDI-Public: 10801902099263
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2025
• Device Catalogue Number: CA-27702
• Device Lot Number: 33F23G0480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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 Sex: Unknown