MAUDE Adverse Event Report: DEROYAL INDUSTRIES INC MEDRAD INJECTO SYRINGE; SYRINGE, PISTON

Model Number 200ML

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 10/06/2014

Event Type  malfunction  

Event Description

When attempting to back up injector syringe during a procedure, a plastic piece on the plunger snapped and got stuck inside.No harm to the patient resulted.Another syringe obtained and procedure continued.

• Brand Name: MEDRAD INJECTO SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): DEROYAL INDUSTRIES INC; 200 debusk lane; powell TN 37849
• MDR Report Key: 4286021
• MDR Text Key: 22062568
• Report Number: 4286021
• Device Sequence Number: 0
• Product Code: FMF
• 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: 11/17/2014

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 Model Number: 200ML
• Device Catalogue Number: 77-400220
• Device Lot Number: IZ572-1405
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2014
• Patient Sequence Number: 0
• Patient Age: 52 YR