MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE LUER LOCK TIP SYR; SYRINGE, PISTON

Model Number	1186000777T
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the syringe tip was breaking off from the vial adapters while mixing chemo inside the chemo drug preparation system.

• Brand Name: 60ML SYRINGE LUER LOCK TIP SYR
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10000891
• Report Number: 1282497-2020-09024
• Device Sequence Number: 2740209
• Product Code: FMF
• UDI-Device Identifier: 10884521189645
• UDI-Public: 10884521189645
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2020

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: No Information
• Device Model Number: 1186000777T
• Device Catalogue Number: 1186000777T
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/27/2020
• Patient Sequence Number: 1