MAUDE Adverse Event Report: BAYER MEDICAL CARE INC BAYER MEDRAD STELLANT FLEX CT SYRINGE WITH TUBING; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number FLEXD-150-SPK

Device Problems Leak/Splash (1354); Defective Device (2588); Incomplete or Inadequate Connection (4037)

Patient Problem Chemical Exposure (2570)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

At (b)(6) hospital, on (b)(6) 2023 in ct, contrast sprayed out of the syringe connection tubing during a patient injection.The contrast came out of a fixed manufacturer connection point, not from a connection point that the staff connects manually.The is potentially dangerous because it could introduce air into the patient.It could also spray contrast into the eyes of a patient.Syringe ref # flexd-150-spk, lot # 8624657, exp date 2026-09-30.

• Brand Name: BAYER MEDRAD STELLANT FLEX CT SYRINGE WITH TUBING
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC
• MDR Report Key: 17011216
• MDR Text Key: 316117354
• Report Number: MW5117928
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLEXD-150-SPK
• Device Catalogue Number: FLEXD-150-SPK
• Device Lot Number: 8624657
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian