MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number JP-17702-C

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the catheter moved 4 days after placement.The device was sutured in place.It did not migrate from the patient body and no injury to the patient occurred.No intervention reported.

Manufacturer Narrative

Qn#(b)(4).The customer returned one catheter for evaluation.A box clamp assembly was attached to the catheter body.Visual inspection of the catheter suture wings and box clamp did not reveal any defects or anomalies.The total length of the catheter body measured to be 220 mm which is within specifications of 207-227 mm per product drawing.To functionally test the device, the box clamp assembly was attached to the catheter body.The catheter body was then tugged in both directions while the box clamp was held stationary.The box clamp did not shift position on the catheter body and the catheter was not able to migrate.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit indicates that the suture wings on the catheter hub are the primary means of securement.The ifu also provides guidance on using the box clamp assembly for secondary securement.The customer reported issue of the catheter migrating while in the patient could not be confirmed during the sample investigation.Visual, dimensional, and functional inspections were performed on the returned catheter and box clamp assembly and no issues were identified.A device history record review was performed and no relevant findings were identified.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that the catheter moved 4 days after placement.The device was sutured in place.It did not migrate from the patient body and no injury to the patient occurred.No intervention reported.

• Brand Name: ARROW CVC SET: 2-LUMEN 7FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8960145
• MDR Text Key: 156453020
• Report Number: 3006425876-2019-00658
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: JP-17702-C
• Device Lot Number: 71F14L1062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1