MAUDE Adverse Event Report: COEUR LABORATORIES DEROYAL 200ML W/F11 TB MR MARKV; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Catalog Number 77-400220

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Used during an aneurysm clipping.

Manufacturer Narrative

Investigation findings: the product is supplied to deroyal by a vendor.Multiple vendors are listed within the jde operating system.An email was submitted to branch plant 34's qc to request documentation of receipt of the product and vendor identification.The work order information was provided on (b)(4) 2014.The work order did not identify any discrepancies and identified the vendor as coeur.The coc was included within the work order.(b)(4) has been issued to vendor.The sample was forwarded to the vendor on 12/11/2014.Follow up was performed on (b)(6) 2014 to alert the vendor of the approaching due date.No further information is available at this time.Will provide follow ups if information becomes available.

• Brand Name: DEROYAL 200ML W/F11 TB MR MARKV
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): COEUR LABORATORIES; 209 creekside dr; washington NC 27889
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653622333
• MDR Report Key: 4420744
• MDR Text Key: 5419436
• Report Number: 1060680-2014-00040
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K823920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: 77-400220
• Device Lot Number: IZ572-1405
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2014
• Distributor Facility Aware Date: 10/06/2014
• Event Location: Hospital
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR