MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 1-LUMEN 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	AK-04301-J
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the suture was found tangled in the swg upon opening the kit.Checking the swg, it was bent at 30cm from the tip.Therefore, a new kit was used".No patient harm or injury.The issue was found prior to use.
Additional Manufacturer Narrative
Qn#(b)(4) the report that the guide wire was kinked was confirmed through visual examination of the returned sample.One kink was observed on the guide wire body.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings to suggest a manufacturing related cause.The portion of the guide wire that was kinked would have been protected within the assembly tubing during packaging, storage, and shipping, so it cannot be confirmed when the guide wire was damaged.Based on these circumstances, the root cause of this investigation is undetermined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "the suture was found tangled in the swg upon opening the kit.Checking the swg, it was bent at 30cm from the tip.Therefore, a new kit was used".No patient harm or injury.The issue was found prior to use.

• Brand Name: ARROW CVC KIT: 1-LUMEN 5 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18602522
• Report Number: 3006425876-2024-00114
• Device Sequence Number: 9033765
• Product Code: DQY
• UDI-Device Identifier: 00801902101914
• UDI-Public: 00801902101914
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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 Expiration Date: 04/28/2026
• Device Catalogue Number: AK-04301-J
• Device Lot Number: 71F22K0370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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