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

Model Number	16-N251S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The safety cap is hard to close over exposed needle causing potential needle stick as you push down to cover needle after use.We received several boxes and all are the same.Plastic cover appears to be small and requires a force to close - potentially sliding finger over needle.
Event or Problem Description
The safety cap is hard to close over exposed needle causing potential needle stick as you push down to cover needle after use.We received several boxes and all are the same.Plastic cover appears to be small and requires a force to close - potentially sliding finger over needle.

• 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: 13558887
• Report Number: 13558887
• Device Sequence Number: 4195071
• Product Code: FMI
• UDI-Device Identifier: 10612479244624
• UDI-Public: (01)10612479244624
• 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): 01/31/2022
• Report Date (Section F): 01/31/2022

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
• Operator of Device: Health Professional
• Device Model Number: 16-N251S
• Device Catalogue Number: 16-N251S
• Device Lot Number: CSOA-06-06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 02/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2022
• 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: 01/31/2022