MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 8CM; CATHETER, PERCUTANEOUS

Catalog Number SAC-00820

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the swg (spring wire guide) in kinked prior to patient use and during inspection.

Event Description

The customer reports that the swg (spring wire guide) in kinked prior to patient use and during inspection.

Manufacturer Narrative

(b)(4).The customer returned one opened set for evaluation.Visual analysis revealed the guide wire contained one distinct kink.The returned packaging and guide wire tubing was also bent in the corresponding location of the guide wire kink.This damage is consistent with defects related to shipping and handling of similar sets.A "do not bend" stamp was on the product lidstock in two locations.The returned guide wire contained one distinct kink 142 mm from the distal end.The total length of the guide wire measured to be 350 mm which is within specifications of 345-355 mm per product drawing.The outer diameter of the guide wire measured to be 0.510 mm which is within specifications of 0.508-0.533 mm per product drawing.The returned guide wire was able to pass through the returned introducer needle and catheter with slight resistance encountered at the kink.A manual tug test confirmed both welds were fully intact.A device history record review was performed with no relevant findings.The reported complaint that the guide wire was found kinked prior to use was confirmed through visual inspection of the returned sample.The returned guide wire contained one distinct kink.The packaging was also found kinked or bent.The guide wire met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer description and the sample received, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL CATH SET: 20GA X 8CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9427125
• MDR Text Key: 169715272
• Report Number: 3006425876-2019-01023
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K093050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/12/2024
• Device Catalogue Number: SAC-00820
• Device Lot Number: 71F19D0135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1