MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD® STELLANT STERILE DISPOSABLE SYRINGE; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number SDS-CTP-SCS

Device Problem Disconnection (1171)

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

Event Date 12/19/2019

Event Type  malfunction  

Event Description

After syringe tubing was connected to patient's piv, the syringe tubing became disconnected at the female port lure lock upon infusion of contrast.

• Brand Name: MEDRAD® STELLANT STERILE DISPOSABLE SYRINGE
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 9641606
• MDR Text Key: 176787600
• Report Number: 9641606
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2020,01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SDS-CTP-SCS
• Device Catalogue Number: SDS-CTP-SCS
• Device Lot Number: 8567906
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2020
• Date Report to Manufacturer: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA