MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 1-3/4"; WIRE ,GUIDE, CATHETER

Catalog Number RA-04020

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports an incident involving the tip/end area of the plastic catheter/cannula that is over the needle of this product that sheared almost completely off.There was no patient complications.

Event Description

The customer reports an incident involving the tip/end area of the plastic catheter/cannula that is over the needle of this product that sheared almost completely off.There was no patient complications.

Manufacturer Narrative

(b)(4).The customer did not return a complaint sample; however, they supplied a photo showing the complaint sample.The photo shows a radial artery (ra) catheterization device with a torn/split catheter.The needle bevel of the device appears to be protruding through the body of the catheter near the distal tip.Blood is visible on the device tip indicating the device was used.A probable cause of the catheter damage cannot be determined from the photo and without the sample returned to evaluate.A device history record review was performed on the ra device (including the catheter) and no relevant findings were identified.The instructions-for-use (ifu) supplied with this kit describes suggested techniques for catheter insertion to mitigate damage to the catheter.It cautions the user "do not reinsert needle into catheter to minimize risk of catheter damage." the ifu also states "care should be exercised that indwelling catheter is not inadvertently kinked at hub area when securing catheter to patient.Kinking may weaken wall of catheter and cause a fraying or fatigue of material, leading to possible separation of the catheter." the report that the catheter tip from the ra device was split/torn was confirmed through examination of the customer supplied photo.The image shows the ra catheter with the needle protruding through the distal end of the catheter body; however, the actual complaint sample was not returned for evaluation.The device history records for the device were reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the catheter damage could not be determined based upon the information provided and without the actual complaint sample to evaluate.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW RA CATH SET: 20 GA X 1-3/4"
• Type of Device: WIRE ,GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7481060
• MDR Text Key: 107205512
• Report Number: 9680794-2018-00098
• Device Sequence Number: 1
• Product Code: DQX
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: RA-04020
• Device Lot Number: 14F17M0223
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1