MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT; SYRINGE, PISTON

Model Number	8881501368
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Staff gave the patient his vaccination and the needle hub broke off into patients arm and detached itself from syringe.

• Brand Name: MONOJECT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13541619
• Report Number: 13541619
• Device Sequence Number: 4456812
• Product Code: FMF
• UDI-Device Identifier: 20884521014012
• UDI-Public: 20884521014012
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2021
• Report Date (Section F): 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8881501368
• Device Catalogue Number: 8881501368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 02/16/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/23/2021