MAUDE Adverse Event Report: MEDTRONIC ACCUMIST BLOWER/MISTER; LAVAGE, JET

Model Number 29150

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 08/07/2017

Event Type  malfunction  

Event Description

Tubing ruptured approximately 8 inches from hand piece during the procedure.

• Brand Name: ACCUMIST BLOWER/MISTER
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6800138
• MDR Text Key: 82992399
• Report Number: MW5071611
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• 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: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 29150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR