MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. MCKESSON SYRINGE/NDL,TB, 1CC; SYRINGE, PISTON

Model Number	16-SNT1C2705
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
When i unpacked the syringe, the top came off.I had to hold the needle portion in place to take the safety off and draw up the syringe.The major issue is when i inserted the needle to give the tb heparin and as i pushed the plunger the syringe was completely removed from the needle due to the small amount of pressure of pushing the plunger.The heparin went everywhere and into my left eye.Due to this, the needle was also stuck and still in the patient's skin.I had to pull it out and safety cap it.These syringes are impossible to use safely.

• Brand Name: MCKESSON SYRINGE/NDL,TB, 1CC
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 1125 sycamore road; manteno IL 60950
• MDR Report Key: 16042320
• Report Number: 16042320
• Device Sequence Number: 6230517
• Product Code: FMF
• UDI-Device Identifier: 10612479207322
• UDI-Public: 10612479207322
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/30/2022
• Report Date (Section F): 11/30/2022

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-SNT1C2705
• Device Lot Number: 164132
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2022
• 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: 11/30/2022