MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARTERIAL CATHETERIZATION KIT; ALINE KIT

Lot Number 23F16F0702

Device Problems Bent (1059); Component Missing (2306)

Patient Problem No Information (3190)

Event Date 12/22/2016

Event Type  malfunction  

Event Description

Femoral aline kit had bent guide-wire prior to it being used.The j-hook was absent and was bent / crooked the last 2" of the guide-wire.

• Brand Name: ARTERIAL CATHETERIZATION KIT
• Type of Device: ALINE KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; reading PA 19605
• MDR Report Key: 6232446
• MDR Text Key: 64366708
• Report Number: MW5067093
• Device Sequence Number: 1
• Product Code: DQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Lot Number: 23F16F0702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 84