MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ACCESS TRAY; CATHETER, PERCUTANEOUS

Catalog Number UM-04018

Device Problem Unraveled Material (1664)

Patient Problem Insufficient Information (4580)

Event Date 10/10/2022

Event Type  malfunction  

Event Description

Medwatch form received reports: "physician was inserting an arterial line, and the guide wire unraveled when being pulled out.".

Manufacturer Narrative

(b)(4).Medwatch report# mw5113148.

Manufacturer Narrative

(b)(4).Medwatch report# mw5113148.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed with one relevant finding.For material d-04218-002a and lot 13c22a0558, a non-conformance was initiated for incomplete component.It cannot be determine if this non-conformance is associated with the complaint issue without the sample returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Medwatch form received reports: "physician was inserting an arterial line, and the guide wire unraveled when being pulled out.".

• Brand Name: ARROW ACCESS TRAY
• Type of Device: 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: 15973728
• MDR Text Key: 306161640
• Report Number: 9680794-2022-00770
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

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 Operator: Health Professional
• Device Catalogue Number: UM-04018
• Device Lot Number: 13F22F0699
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED