MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARTERIAL LINE KIT; ARTERIAL CATHETER PRODUCTS

Catalog Number VASCULAR UNKNOWN

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2014

Event Type  malfunction  

Event Description

Information provided via medwatch report.It was reported the procedure was being performed on a (b)(6) male patient.During the a-line insertion to prepare the patient for a scheduled surgery, the wire "popped" through a defect in a plastic.The a-line and wire were removed.Unable to thread iv and had to be removed.X-ray was done to make sure there was no remains of the wire in the patient.An exploration for a-line fragments was also done.After verification, the surgeon moved forward with the scheduled procedure.

Manufacturer Narrative

(b)(4).Sample will not be returned for evaluation.

• Brand Name: ARTERIAL LINE KIT
• Type of Device: ARTERIAL CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: alice harper ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4296329
• MDR Text Key: 5270183
• Report Number: 1036844-2014-00455
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2014

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 Catalogue Number: VASCULAR UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR