MAUDE Adverse Event Report: TELEFLEX NADC ARROWG+ARD BLUE PLUS; CATHETER, PERCUTANEOUS

Catalog Number ASK-45703-PHPA2

Device Problems Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 08/27/2015

Event Type  malfunction  

Event Description

An er doctor was here to insert a triple lumen catheter on a pt.The doctor reported that when she had the guide wire in place, the actual catheter itself would not thread, as it was too small of a diameter.

• Brand Name: ARROWG+ARD BLUE PLUS
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TELEFLEX NADC; 11245 n distribution cove; olive branch MS 38654
• MDR Report Key: 5093534
• MDR Text Key: 26447556
• Report Number: 5093534
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: ASK-45703-PHPA2
• Device Lot Number: 23F14M0415
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1