MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PEDIATRIC JUGULAR SET: 20 GA X 5" (12 CM; CATHETER PERCUTANEOUS

Catalog Number ES-04150

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: "md was performing the procedure according to ifu.But swg was kinking during insertion.Md judged it as a defective product so finished the procedure with new kit without abnormality".No patient harm reported.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The customer returned multiple components from a pediatric kit.The guide wire and introducer needle will be analyzed as part of this complaint investigation.Signs-of-use in the form of biological material was observed on the guide wire.The guide wire was returned stuck inside the introducer needle.Visual analysis revealed that the guide wire was kinked towards the distal end.Offset coils were also observed at the kink.This resulted in the distal j-bend to be slightly misshapen.Microscopic examination confirmed the kink and revealed that the distal end proximal welds were secure and intact.The kink in the guide wire measured 25mm from the distal weld.The guide wire total length measured outer diameter measured 13 15/16", which is within the specification limits of 13 25/32"-14" per the guide wire graphic.The guide wire outer diameter measured.61mm, which is within the specification limits of.610mm-.635mm per the guide wire graphic.The introducer needle outer diameter measured.0355", which is within the specification limits of.0355"-.0360" per the cannula graphic.The guide wire inner diameter measured at the distal and proximal end measured.027", which is within the specification limits of.0270"-.0285" per the cannula graphic.The proximal end of the guide wire was inserted through the introducer needle.Little to no resistance was observed as the guide wire was able to pass completely through the assembly.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested".The ifu also states, "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide".The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire was kinked towards the distal end.The kink in combination with dried biological material likely resulted in the resistance encountered by the customer.Despite this, the guide wire and the needle met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: "md was performing the procedure according to ifu.But swg was kinking during insertion.Md judged it as a defective product so finished the procedure with new kit without abnormality".No patient harm reported.The patient's condition was reported as fine.

• Brand Name: ARROW PEDIATRIC JUGULAR SET: 20 GA X 5" (12 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10584393
• MDR Text Key: 208767132
• Report Number: 9680794-2020-00383
• 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: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: ES-04150
• Device Lot Number: 14F19H0349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.