MAUDE Adverse Event Report: ARROW MAC KIT; CATHETER INTRAVASCULAR THERAPE

Catalog Number VASCULAR UNKNOWN

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 08/14/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The mdr report key is (b)(4).The mdr text key is (b)(4).The report number is mw5103404.

Event Description

Complaint found in maude database: "catheter dialator "bent" and slightly cracked when inserted into the sub-q tissue.Catheter withdrawn.This is for cvc insertions requiring more force to get over/around the clavicle.".

Manufacturer Narrative

(b)(4), the mdr report key is 12353979.The mdr text key is 267974744.The report number is mw5103404.Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

Event Description

Complaint found in maude database: "catheter dialator "bent" and slightly cracked when inserted into the sub-q tissue.Catheter withdrawn.This is for cvc insertions requiring more force to get over/around the clavicle.".

• Brand Name: ARROW MAC KIT
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• MDR Report Key: 12592629
• MDR Text Key: 275471616
• Report Number: 9680794-2021-00514
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

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: VASCULAR UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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