MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ARTERIAL CATHETERIZATION KIT; CATHETER, PERCUTANEOUS

Catalog Number AK-04550-S

Device Problems Positioning Failure (1158); Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

The doctor attempted to place femoral central line.The j-wire would not release after insertion.The wire was removed with the assistance of another doctor.On removal it was noted that the wire was frayed.Pressure dressing applied with 1 hr pulse checks.

• Brand Name: ARTERIAL CATHETERIZATION KIT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); 2400 bernville road; reading PA 19605
• MDR Report Key: 4591761
• MDR Text Key: 21177817
• Report Number: 4591761
• Device Sequence Number: 0
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: AK-04550-S
• Device Lot Number: 23F14E0631
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2015
• Patient Sequence Number: 0
• Patient Age: 70 YR