MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW 4-L CVC KIT: 8.5 FR X 20 CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CDC-45854-1A

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The results of the investigation are incomplete at the time of this report.

Event Description

The customer alleges that the wire was inserted, and when they tried to insert the catheter along the wire, the catheter kinked at the tip and wouldn't go in.The device was thrown away and a new device was obtained and used without issue.

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.The probable cause of the catheter tip defect could not be determined based upon the information provided and without a sample.

Event Description

The customer alleges that the wire was inserted, and when they tried to insert the catheter along the wire, the catheter kinked at the tip and wouldn't go in.The device was thrown away and a new device was obtained and used without issue.

• Brand Name: ARROW 4-L CVC KIT: 8.5 FR X 20 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6540707
• MDR Text Key: 74313978
• Report Number: 3003737899-2017-00042
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: CDC-45854-1A
• Device Lot Number: 13R16L0328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2017
• 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