MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3-LUMEN 5.5 FR X 8 CM; CATHETER PERCUTANEOUS

Catalog Number	AK-15553
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "wire showed visible defect in the proximal/initial bend of the j-tip." the issue was identified prior to use.
Additional Manufacturer Narrative
(b)(4).The customer provided two photos for analysis.The complaint of a kinked guide wire was able to be confirmed by the photos.The customer also returned a representative ak-15553 cvc kit for evaluation.The kit was opened to further analyze the components.The contents within the kit were mispositioned which is consistent with storage and shipping; however, visual analysis of the guide wire assembly and other components revealed no damage.The overall length of the guide wire measured 450 mm, which is within the specification limits of 449.2-458.8 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.439 mm, which is within the specification limits of 0.432-0.457 mm per guide wire product drawing.The guide wire was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through the returned 21ga introducer needle to functionally test the guide wire.The guide wire passed through with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with the kit informs the user, "do not use if package is damaged." the report of a guide wire kinked in package was not confirmed through complaint investigation of the returned sample.The customer returned an unopened, representative ak-15553 kit.No defects or anomalies were observed on the returned guide wire.The returned guide wire met all relevant dimensional/functional requirements.A device history record review did not identify any manufacturing related issues.Based on the customer report and the returned representative sample, the probable cause for the reported guide wire cannot be determined without the actual guide wire returned.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "wire showed visible defect in the proximal/initial bend of the j-tip." the issue was identified prior to use.

• Brand Name: ARROW CVC KIT: 3-LUMEN 5.5 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20188327
• Report Number: 9680794-2024-00867
• Device Sequence Number: 7003184
• Product Code: DQY
• UDI-Device Identifier: 10801902122107
• UDI-Public: (01)10801902122107(11)240624(17)260731(10)33F24E0714(21)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 07/31/2026
• Device Catalogue Number: AK-15553
• Device Lot Number: 33F24E0714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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