MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 20 CM AGB; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CDC-45703-XP1A

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).No sample will be returned for evaluation.This report is for the first in a series of five consecutive product problems with the same patient.The second, third, fourth and fifth have been reported under mdr # 1036844-2016-00182, 1036844-2016-00183, 1036844-2016-00184, 1036844-2016-00185.

Event Description

Information was found during the maude event website search.It was reported that on (b)(6) 2016 the patient arrived in the emergency department coding with minimal vascular access available.Multiple iv attempts.Physician made multiple central line attempts to gain central venous access.Each attempt resulted in a kinked guide wire.The physician had to pull the equipment out of the patient and reattempt.

• Brand Name: PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5530205
• MDR Text Key: 41304848
• Report Number: 1036844-2016-00181
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F15J0872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2015
• 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
• Patient Outcome(s): Required Intervention