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

Catalog Number CDC-45703-1A

Device Problems Unraveled Material (1664); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample will be returned for evaluation.

Event Description

It was reported the procedure was being performed in the emergency department.The physician stated the guide wire has unraveled during the procedure.There was no injury to the patient.No patient death or complications reported.Follow up information states the guide wire was being fed through the needle.The guide wire became stuck during insertion or removal in some cases.A second kit was used to complete the procedure successfully.Patient care was delayed.In each case the physician had to remove the needle to safely remove the wire and then re-establish access.On at least one occasion they had to use a different insertion site.

• Brand Name: 3-L CVC KIT: 7 FR X 20 CM
• 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: 6092440
• MDR Text Key: 59721112
• Report Number: 1036844-2016-00570
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993691
• 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
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: CDC-45703-1A
• Device Lot Number: 23F16E0704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2016
• 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