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

Model Number	102-N2558S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
While preforming an injection, i discovered the "prevent ht safety hypodermic needle 25 x 5/8" safety cover did not properly latch on to the needle securing the needle when the immunization was done.Then attempted to put the safety securely on the needle by using gentle pressure against the counter and the plastic safety snapped exposing the needle.
Event or Problem Description
While preforming an injection, i discovered the "prevent ht safety hypodermic needle 25 x 5/8" safety cover did not properly latch on to the needle securing the needle when the immunization was done.Then attempted to put the safety securely on the needle by using gentle pressure against the counter and the plastic safety snapped exposing the needle.

• Brand Name: MCKESSON
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 9954 mayland dr; richmond VA 23233
• MDR Report Key: 12347676
• Report Number: 12347676
• Device Sequence Number: 3661710
• Product Code: MEG
• UDI-Device Identifier: 30612479178824
• UDI-Public: (01)30612479178824
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021
• Report Date (Section F): 08/02/2021

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: 102-N2558S
• Device Lot Number: LOT 201029B
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/20/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/28/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/02/2021