MAUDE Adverse Event Report: SHENZHEN BOON MEDICAL SUPPLY CO., LTD. / MEDICAL IMAGING SOLUTIONS INTERNATIONAL CT ANGIOGRAPHIC SYRINGE; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Catalog Number 200101

Device Problems Break (1069); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/21/2020

Event Type  Injury  

Event Description

The patient came into ct suite from the emergency room for a ct angiogram of the chest with contrast.After consent was obtained, the patient's iv line was checked for patency by flushing the line with normal saline and connected to the syringe containing contrast medication in the power injector.Once the exam was started and contrast injection started, it was noticed that the luer-lock of the syringe in the injector had broken off and the contrast material had emptied onto the patient, table and floor.A second attempt was made using a new injector syringe filled with contrast material, but this time the iv catheter in the patient's arm failed.No harm happened to the patient, but exam was not able to be completed as ordered.Ref# (b)(4).

• Brand Name: CT ANGIOGRAPHIC SYRINGE
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): SHENZHEN BOON MEDICAL SUPPLY CO., LTD. / MEDICAL IMAGING SOLUTIONS INTERNATIONAL
• MDR Report Key: 10032282
• MDR Text Key: 190322985
• Report Number: MW5094402
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/01/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Catalogue Number: 200101
• Device Lot Number: 20191124
• 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 Outcome(s): Required Intervention