MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PEDIATRIC JUGULAR SET: 20 GA X 5"; CATHETER PERCUTANEOUS

Catalog Number ES-04150

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

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the guide wire was found to be kinked after package was opened.

Manufacturer Narrative

Qn#(b)(4).The customer returned a single spring wire guide (swg) out of its assembly.The guide wire was observed to have two kinks at the distal end and a slight bend at the proximal end.Visual inspection of the packaging could not be performed to evaluate poor storage and shipping technique because no packaging was returned.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The kinks in the guide wire were located at 307mm and 315mm from the proximal tip.The bend was located 20mm from the proximal tip.The overall length of the guide wire measured 355mm which is within the specification of 350-355.6mm per guide wire product drawing.The outer diameter of the guide wire measured 0.615mm which is within the specification of 0.610-0.635mm per guide wire product drawing.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed and no relevant findings were identified.The report that the guide wire kinked during use was confirmed through examination of the returned sample.A visual examination of the packaging could not be performed since it was not returned.The returned guide wire met all relevant dimensional requirements and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed before use, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: the guide wire was found to be kinked after package was opened.

• Brand Name: ARROW PEDIATRIC JUGULAR SET: 20 GA X 5"
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9279682
• MDR Text Key: 177798913
• Report Number: 9680794-2019-00428
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K810962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: ES-04150
• Device Lot Number: 14F17M0192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1