MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 14GA X 20CM

Model Number IPN030979

Device Problems Crack (1135); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device (catalog # de-04701-cp) not intended for sale in the us.Similar device/component sold in the us.

Event Description

The customer reports that the needle hub cracked after puncture.During aspiration air was pulled.

Event Description

The customer reports that the needle hub cracked after puncture.During aspiration air was pulled.

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided one photo of a lidstock for evaluation.The needle hub damage could not be confirmed as it was not pictured in the photo.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit instructs the user, "locate central vein with a 22 ga.Needle and syringe.Insert introducer needle with attached syringe into vein alongside of locator needle and aspirate until good venous blood flow is established." the complaint could not be confirmed by the customer photo.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.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC KIT: 14GA X 20CM
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10122890
• MDR Text Key: 194689951
• Report Number: 3006425876-2020-00495
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/25/2020

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 Expiration Date: 08/31/2023
• Device Model Number: IPN030979
• Device Catalogue Number: DE-04701-CP
• Device Lot Number: 71F19K0463
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1