MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER PERCUTANEOUS

Catalog Number ES-04301

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed , and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed , and the probable cause could not be determined from the available information.The ifu provided with this kit instructs the user, "secure catheter to patient.Use integral side wings as primary suture site.In kits where provided, the catheter clamp and fastener should be utilized as a secondary suture site as necessary.Precaution: do not suture directly to outside diameter of catheter to minimize the risk of cutting or damaging the catheter or impeding catheter flow" teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that on (b)(6) 2019, in yangzhou east hospital, the fixed catheter was found moved from 13cm to 8cm during usage on the patient.When checking the catheter and the clamp, the user that they did not match well, and the catheter could move freely, which caused the catheter slip.

• Brand Name: ARROW CVC SET: 16 GA X 8" (20 CM)
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 8662541
• MDR Text Key: 146807562
• Report Number: 3006425876-2019-00427
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: ES-04301
• Device Lot Number: 71F16C1929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2016
• 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