MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC; CATHETER

Device Problem Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Date 12/27/2014

Event Type  malfunction  

Event Description

Attending physician in the picu emergently needed to place a central line on a critical patient.Opened an arrow 4 french 8 cm double lumen cath and found it to be crimped at the proximal port,second kit opened but found to be curled and attending was unable to straighten.

• Type of Device: CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL, INC; 2400 bernville road; reading, PA 19605
• MDR Report Key: 4477930
• MDR Text Key: 5564666
• Report Number: 4477930
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2015
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 23 MO
• Patient Weight: 10