MAUDE Adverse Event Report: INTEGRA JARIT #12 FRAZIER SUCTION DEVICE ; APPARATUS, SUCTION

Model Number 285-456

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Brain Injury (2219)

Event Date 03/29/2017

Event Type  malfunction  

Event Description

Surgeon was using a 12 french frazier suction.States a sharp point at the tip of the suction punctured the dura, causing a dural tear.

• Brand Name: #12 FRAZIER SUCTION DEVICE
• Type of Device: APPARATUS, SUCTION
• Manufacturer (Section D): INTEGRA JARIT; plainsboro NJ 08536
• MDR Report Key: 6456321
• MDR Text Key: 71725664
• Report Number: MW5068861
• Device Sequence Number: 1
• Product Code: JZF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2017
• Device Model Number: 285-456
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 115