MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH KIT: 20 GA X 1 3/4 IN; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04020-ATH
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "crna accessed artery, had blood flow.Could not advance catheter.It did not move, felt stuck to the whole device.Pulled everything out.Needle was disengaged and sheared.She successfully replaced with a another device." there was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).Awareness date was corrected to 17may2024 due to an additional complaint request by the investigation engineer on 17apr2024.
Event or Problem Description
It was reported that: "crna accessed artery, had blood flow.Could not advance catheter.It did not move, felt stuck to the whole device.Pulled everything out.Needle was disengaged and sheared.She successfully replaced with a another device." there was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of the needle cannula separating from the needle hub was confirmed based on visual analysis of the customer photos.The photos show the proximal end of the needle cannula separated from the needle hub.The appearance of the damage is consistent with a manufacturing defect.Manufacturing was contacted as a part of this complaint investigation.They stated that the observed defect in the customer photo is a manufacturing issue during the assembly process.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, "precaution: if resistance is encountered during guidewire advancement do not force feed, withdraw entire unit and attempt new puncture.Warning: do not use excessive force in removing catheter.If resistance is met on removal , stop and follow institutional policies and procedures for difficult to remove catheters." the customer report of the needle cannula separating from the needle hub was confirmed by visual inspection of the customer supplied photos.The photos show the proximal end of the needle cannula separated from the needle hub.Based on the appearance of the damage, manufacturing likely caused or contributed to the event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section b.3.Corrected to 29-feb-2024.

• Brand Name: ARROW RA CATH KIT: 20 GA X 1 3/4 IN
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 19215189
• Report Number: 9680794-2024-00441
• Device Sequence Number: 15503419
• Product Code: DQX
• UDI-Device Identifier: 10801902164244
• UDI-Public: 10801902164244
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• 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): 04/17/2024

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: 12/31/2024
• Device Catalogue Number: ASK-04020-ATH
• Device Lot Number: 33F23K0784
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2023
• 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