MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 20 GA X 1-1/2; WIRE GUIDE CATHETER

Catalog Number RA-04220

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer returned one arterial catheterization device for evaluation.Two (2) arterial catheters were returned.One of them did not show any evidence of use, therefore it is being assumed that this catheter is representative.The remaining returned components showed evidence of use.Visual analysis revealed that the catheter body was severed towards the catheter hub.Microscopic examination confirmed the damage and revealed that the point of separation was angled and showed no evidence of stretching, which is damage consistent with contact with sharps (i.E.Needle bevel).The catheter body was separated 3mm from the catheter hub.The catheter body outer diameter measured 0.045", which is within the specification limits of 0.045"-0.047" per the catheter extrusion product drawing.The catheter body inner diameter at the point of separation measured 0.035", which is within the specification limits of 0.035"-0.037" per the catheter extrusion product drawing.This indicates the catheter wall thickness was within specification.Functional inspection could not be accurately performed due to the damage.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not reinsert needle into catheter; doing so may result in patient injury or catheter damage".The report of a separated catheter was confirmed through complaint investigation.Visual analysis revealed that the catheter body was severed towards the catheter hub.The separated end was not returned.The appearance of the points of separation are consistent with damage resulting from the catheter coming in contact with the needle bevel.Despite the damage, the sample met all relevant dimensional 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 Description

An arterial catheterization device was returned with with two arterial catheters.It was discovered that one of the catheters was severed toward the hub.Several attempts were made to contact the customer to gather additional information regarding the returned device; however, no response has been received at the time of this report.

• Brand Name: ARROW RA CATH SET: 20 GA X 1-1/2
• Type of Device: 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18952097
• MDR Text Key: 338305404
• Report Number: 9680794-2024-00296
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00801902002761
• UDI-Public: 00801902002761
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: RA-04220
• Device Lot Number: 14F23D0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• 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: NONE REPORTED