MAUDE Adverse Event Report: CAREFUSION 2200, INC. AVAMAX; AVAMAX PLUS NEEDLE

Catalog Number VMX00CT

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2014

Event Type  malfunction  

Event Description

During fluoroscopic guided spine vertebroplasty, an avamax plus 11g inner cannula broke off inside needle within the patient.The radiologist had to inject a second needle without the cannula.The cannula fragment stayed with the needle and was removed from the patient.No patient harm occurred.

• Brand Name: AVAMAX
• Type of Device: AVAMAX PLUS NEEDLE
• Manufacturer (Section D): CAREFUSION 2200, INC.; 1500 waukegan road; waukegan IL 60085
• MDR Report Key: 4397301
• MDR Text Key: 16852207
• Report Number: 4397301
• Device Sequence Number: 1
• Product Code: NDN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: VMX00CT
• Device Lot Number: 0000696554
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 41 YR
• Patient Weight: 72