MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. MCKESSON; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	26559
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Went to use an unopened mckesson brand prevent m safety needle 25gx 1", lot # 922693, exp 6/30/24 and found that the hub of the needle had a green substance on it and it did not appear sterile or appropriate for use.

• Brand Name: MCKESSON
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 9954 mayland dr; richmond VA 23233
• MDR Report Key: 9574633
• Report Number: 9574633
• Device Sequence Number: 11407748
• Product Code: FMI
• UDI-Device Identifier: 10612479201382
• UDI-Public: (01)10612479201382
• 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): 11/19/2019
• Report Date (Section F): 12/17/2019

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: 26559
• Device Lot Number: 922693
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/17/2019