MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. MCKESSON; SYRINGE, PISTON

Model Number	16-S10C
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The outside of the package says "syringe 10cc" but when you flip it over and really look at the graduation lines that are on the syringe go to 12cc/ml.

• Brand Name: MCKESSON
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 1125 sycamore road; manteno IL 60950
• MDR Report Key: 15690330
• Report Number: 15690330
• Device Sequence Number: 7368170
• Product Code: FMF
• UDI-Device Identifier: 10612479206882
• UDI-Public: (01)10612479206882
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/06/2022
• Report Date (Section F): 10/06/2022

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
• Device Model Number: 16-S10C
• Device Lot Number: CKDB04-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 10/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/06/2022