MAUDE Adverse Event Report: Q-MED AB DEFLUX; AGENT, BULKING, INJECTABLE

Lot Number 11889-2

Device Problem Break (1069)

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

Event Date 12/16/2013

Event Type  malfunction  

Event Description

Deflux injection syringe tip broke while physician attempting to flush deflux through syringe.

• Brand Name: DEFLUX
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AB; 909 third ave; 909 third ave; new york NY 10022
• MDR Report Key: 3657477
• MDR Text Key: 4282289
• Report Number: 3657477
• Device Sequence Number: 1
• Product Code: LNM
• 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: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 11889-2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2014
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 19