MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number ASK-15703-KR

Device Problems Leak/Splash (1354); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device product is not intended for sale in the us.Similar device product sold in the us.

Event Description

The customer alleges that during use, the device leaked.The user found the extension line of the proximal lumen was cut.The catheter was replaced.No patient injury.

Manufacturer Narrative

(b)(4).The report that the extension line separated from the catheter was confirmed by visual examination of the returned sample.Microscopic examination determined that the separated end of the catheter extension line had a smooth appearance consistent with contact with a sharp object.A device history record review did not reveal any manufacturing related issues.The extension line met all relevant dimensional requirements.Based on the appearance of the extension line and the report that the event occurred during use, operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer alleges that during use, the device leaked.The user found the extension line of the proximal lumen was cut.The catheter was replaced.No patient injury.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 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: linda woodall ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9196942566
• MDR Report Key: 6753865
• MDR Text Key: 81397263
• Report Number: 3006425876-2017-00240
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

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: No Information
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: ASK-15703-KR
• Device Lot Number: 71F16L0067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 07/31/2017
• Supplement Dates Manufacturer Received: 09/06/2017
• Supplement Dates FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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