MAUDE Adverse Event Report: ARROW INTL., INC. HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; ACUTE HEMODIALYSIS CATHETER PRODUCTS

Catalog Number CS-15122-F

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2014

Event Type  malfunction  

Event Description

It was reported that prior to insertion, the guidewire was found to be bent.As a result, a new kit was opened and used without issue.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4).

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: ACUTE HEMODIALYSIS CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: john george, specialist ; 2400 bernville rd.; reading, PA 19605
• MDR Report Key: 4350321
• MDR Text Key: 22065962
• Report Number: 1036844-2014-00515
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K895417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2014

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: 06/30/2016
• Device Catalogue Number: CS-15122-F
• Device Lot Number: 23F14F0071
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2014
• Initial Date FDA Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• 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